Significant Reduction In HbA1c Levels Research Articles

Effects of nonsurgical periodontal therapy in patients with moderately controlled type 2 diabetes mellitus and chronic periodontitis in Nepalese population.

ObjectivesDespite several investigations, evidence is still controversial regarding the effect of periodontal treatment on diabetes. This study evaluates and compares the effect on glycemic control and periodontal status with or without nonsurgical periodontal therapy in patients with type 2 diabetes mellitus and chronic periodontitis in a Nepalese population.Materials and methodsA total of 82 patients attending the diabetes clinic and fulfilling enrollment criteria with moderate to severe periodontitis were selected. They were assigned in an alternative sequence, into test and control group. Both groups were instructed to continue with their medical treatment without modifications. Scaling and root surface debridement were performed in the test group whereas the control group received oral hygiene instructions with no treatment during the 3-month study period.ResultsThere were 41 participants in each group with the mean age of 50.66±7.70 and 53.80±9.16 years, average diabetes duration of 6.32±4.21 and 6.24±4.00 years, mean body mass index of 24.78±1.85 and 24.6±1.79 kg/m2, and glycated hemoglobin (HbA1c) level of 6.71±0.50% and 6.80±0.45%, in the test and control group, respectively. After 3 months, there was significant reduction in HbA1c levels in the test group compared to the control group (p=0.029). Clinical periodontal parameters of gingival index, probing depth (PD), and clinical attachment level (CAL) significantly improved in the test group (p<0.001) with PD reduction by 0.9 mm and gain in CAL by 0.3 mm compared to the control group (p>0.001) who showed an increase by 0.05 mm.ConclusionThis study showed that nonsurgical periodontal therapy may have a beneficial effect on HbA1c level in moderately controlled type 2 diabetic patients.

Oral repaglinide versus insulin injection in type II diabetes mellitus; a randomized clinical trial

Introduction: Glycemic control at the level of normal condition is considered as a key point for preventing of complications like metabolic disturbances as well as renal pathologies in type II diabetes mellitus (DM). Objectives: Presented study was designed to find suitable method for reducing hyperglycemic pathologies like normalizing of albuminuria, postprandial blood sugar (BS), HbA1c, fasting blood sugar (FBS) and C-peptide levels by administration of insulin injection versus oral repaglinide. Patients and Methods: A total of 56 cases of type II DM were enrolled in this study and randomly divided into two groups of 28 subjects receiving regular insulin (control group) and repaglinide tablets (cases group) in accordance with inclusion and exclusion criteria. Glycemic profile and levels of albuminuria were measured and analyzed during 12 weeks. Results: Changes in levels of FBS, 2 hours postprandial (2hpp) BS and HbA1c were not showed in both groups (P = 0.096) but C-peptide levels were decreased in the repaglinide group (P = 0.001). Hypoglycemia was observed in 21.4% of control group. Statistically significant reduction in HbA1c levels was not observed despite a greater impact of regular soluble insulin on postprandial glucose (P = 0.096). Weight gain in insulin group was more (P = 0.042) and hypoglycemic events were lower in repaglinide group. Additionally, reduction in microalbuminuria was not statistically significant (P = 0.73) in both groups. Conclusion: Based on our findings, repaglinide is suitable candidate for preventing undesirable side effects through regular soluble insulin using for type II DM treatment.

Effect on cardiovascular disease risk factors of interventions to alter consultations between practitioners and patients with type 2 diabetes: A systematic review and meta-analysis of trials in primary care.

ObjectiveTo examine the effect on cardiovascular (CVD) risk factors of interventions to alter consultations between practitioners and patients with type 2 diabetes.Search StrategyElectronic and manual citation searching to identify relevant randomized controlled trials (RCTs).Inclusion Criteria RCTs that compared usual care to interventions to alter consultations between practitioners and patients. The population was adults aged over 18 years with type 2 diabetes. Trials were set in primary care.Data extraction and synthesisWe recorded if explicit theory‐based interventions were used, how consultations were measured to determine whether interventions had an effect on these and calculated weighted mean differences for CVD risk factors including glycated haemoglobin (HbA1c), systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), LDL cholesterol (LDL‐C) and HDL cholesterol (HDL‐C).ResultsWe included seven RCTs with a total of 2277 patients with type 2 diabetes. A range of measures of the consultation was reported, and underlying theory to explain intervention processes was generally undeveloped and poorly applied. There were no overall effects on CVD risk factors; however, trials were heterogeneous. Subgroup analysis suggested some benefit among studies in which interventions demonstrated impact on consultations; statistically significant reductions in HbA1c levels (weighted mean difference, −0.53%; 95% CI: [−0.77, −0.28]; P<.0001; I 2=46%).ConclusionsEvidence of effect on CVD risk factors from interventions to alter consultations between practitioners and patients with type 2 diabetes was heterogeneous and inconclusive. This could be explained by variable impact of interventions on consultations. More research is required that includes robust measures of the consultations and better development of theory to elucidate mechanisms.

Long-Term Effect of Alogliptin on Glycemic Control in Japanese Patients With Type 2 Diabetes: A 3.5-Year Observational Study.

BackgroundThe goal of the current study was to investigate the long-term effects (after 3 years or more) of alogliptin on glycemic control in Japanese patients with type 2 diabetes.MethodsWe retrospectively studied the effect of alogliptin on glycemic control in the patients with type 2 diabetes who had participated in our previous 3-month study and who continued to take alogliptin for at least 36 months.ResultsThe mean duration of alogliptin treatment was 42.8 ± 2.2 months. In all 39 patients, a significant reduction in hemoglobin A1c (HbA1c) levels was noted between the baseline and final visit: 7.8±0.6% to 7.2±1.0% (P = 0.0001). A significant reduction in HbA1c levels was found in a subgroup of patients who did not change their anti-diabetic drugs or did decrease the dose of their sulfonylureas (SUs) or did change to a lower strength repaglinide (n = 32): 7.7±0.6% to 7.2±1.0% (P = 0.0005). A significant decrease in low-density lipoprotein cholesterol (LDL-C) levels was observed in all of the patients that had LDL-C levels determined (P = 0.0406) (n = 37), and in a subgroup of patients who had not taken either statins, fibrates, or pioglitazone, or who had taken one or more of these drugs but the doses were not changed during the observation period (P = 0.0250) (n = 27).ConclusionThe current study found that alogliptin performed well for glycemic control when evaluated by HbA1c levels in a long-term observation period exceeding 3 years in Japanese patients with type 2 diabetes. Alogliptin may also decrease circulating LDL-C levels with long-term use.

A pilot study of D-chiro-inositol plus folic acid in overweight patients with type 1 diabetes.

To improve insulin sensitivity, insulin-sensitizing drugs such as metformin are commonly used in overweight and obese T1D patients. Similarly to metformin, D-chiro-inositol (DCI), as putative mediator of intracellular insulin action, can act as insulin sensitizer. The aim of this pilot study was to evaluate the hypothesis that DCI plus folic acid may improve glucose control reducing insulin resistance in overweight or obese T1D patients. A 24-week randomized control trial was carried out in 26 overweight or obese T1D patients, undergoing intensive insulin therapy. Patients were randomized to 1g DCI plus 400 mcg folic acid once daily (treated group) or to 400 mcg folic acid only once daily (control group). The primary end point was to evaluate the efficacy of DCI on metabolic control as assessed by HbA1c. As secondary endpoints, BMI and insulin requirement (IR) were evaluated. Paired t test (two tailed) and analysis of variance were used to evaluate differences in HbA1c, BMI and IR at different time points. A significant reduction in HbA1c levels in treated group versus control group (7.5%±0.9 vs. 7.9%±1.7, respectively, p<0.05) was observed. However, no significant reduction in BMI and IR was observed [(BMI 25.7±2.8 vs. 26.7±1.0, respectively, p NS); (IR 0.52±0.26 vs. 0.52±0.19, respectively, p NS)]. This trial demonstrated for the first time that DCI plus folic acid oral supplementation can improve metabolic control in overweight T1D patients. CLINICALTRIAL. NCT02730949.

The effect of progressive muscle relaxation on glycated hemoglobin and health-related quality of life in patients with type 2 diabetes mellitus

AimThis study aimed to evaluate the effect of Jacobson’s progressive muscle relaxation (PMR) on glycated hemoglobin (HbA1c) levels and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus (DM). BackgroundDue to relatively poor HRQoL in patients with type 2 DM, different stress reduction techniques was applied to improve physical and mental health in these patients. MethodsThis randomized controlled clinical trial was conducted at the Diabetes and Endocrinology Institute of Firoozgar Hospital, Tehran, Iran, between June and December 2015. Sixty-five patients with type 2 DM were randomly divided into the control (n=35) and PMR (n=30) groups. The patients of the control group only received the conventional care. The PMR group practiced Jacobson’s PMR at home for 12 weeks and were monitored by the researcher’s phone calls and patient’s self-report list. For both groups, Iranian Diabetes Quality of Life Brief Clinical Inventory (IDQoL-BCI) questionnaire was completed and HbA1c levels were measured before and 12 weeks after study entry. ResultsThe results showed that there were no significant differences in terms of HbA1c levels and HRQoL scores between the PMR and control groups 12 weeks after intervention. However, in the PMR group, the intervention led to a significant reduction in HbA1c levels (P=0.04) and a significant increase in total HRQoL score (P=0.045) and its psychosocial dimension (P=0.019). ConclusionPMR had no significant impact on HbA1c levels and HRQoL in patients with type 2 DM. Further studies with larger sample size and longer follow-up are needed to improve QoL in patients with type 2 DM.

Role of lasers as an adjunct to scaling and root planing in patients with type 2 diabetes mellitus: a systematic review.

The aim of the study was to assess the efficacy of adjunctive use of laser therapy (LT) alone or antimicrobial photodynamic therapy (aPDT) to improve clinical periodontal and HbA1c levels in patients with both chronic periodontitis (CP) and type 2 diabetes mellitus (T2DM). Electronic search of the MEDLINE, PubMed, EMBASE, Science Direct, and SCOPUS databases were combined with hand searching of articles published from 1975 up to and including March 2016 using relevant MeSH terms. Six studies were selected for this review. In these six studies, laser treatment was applied, after scaling and root planing (SRP), in two ways: Three studies used laser alone and three studies used laser with photosensitizer. All the six included studies reporting clinical periodontal and glycemic parameters showed that LT and aPDT were effective in the treatment of CP in T2DM subjects at follow-up. Two studies showed significantly better periodontal outcomes for LT as an adjunct to SRP as compared to SRP alone, whereas four studies showed comparable periodontal outcomes among adjunctive LT or aPDT with SRP. Two studies showed significant reduction of HbA1c levels in LT and aPDT as compared to SRP, whereas three studies showed comparable percentage levels at follow-up. It remains debatable whether LT or aPDT as adjunct to SRP is more effective as compared to SRP alone in the improvement of clinical periodontal and glycemic control in patients with both CP and T2DM, given that the scientific evidence is weak.

Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

ObjectiveSeveral intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals.Materials and MethodsParticipants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks.ResultsThe mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks.ConclusionBoth diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms.Trial RegistrationCRiS KCT0001771

Investigating Sources of Heterogeneity in Randomized Controlled Trials of the Effects of Pharmacist Interventions on Glycemic Control in Type 2 Diabetic Patients: A Systematic Review and Meta-Analysis.

ObjectiveTo assess the effect of pharmacist interventions on glycemic control in type 2 diabetic patients and to examine factors that could explain the variation across studies.MethodsA comprehensive literature search was performed in PubMed, Scopus, and LILACS databases for randomized controlled trials (RCTs) published up to July 2015. The search strategy included the use of MeSH terms or text words related to pharmacist interventions, type 2 diabetes, and randomized controlled trials. RCTs published in English, Portuguese, or Spanish that evaluated the effect of pharmacist intervention on glycemic control in type 2 diabetic outpatients were included. Two independent authors executed study selection, data extraction, and risk of bias assessment. Mean differences in glycosylated hemoglobin (HbA1c) were estimated using random-effect models, and heterogeneity was evaluated by subgroup and meta-regression analyses.ResultsThe literature search yielded 963 records of potential interest, of which 30 were included in the systematic review and 22 in the meta-analysis. Most of these RCTs were conducted in the United States in patients in outpatient clinics using face-to-face contact only. All RCTs performed patient education, and most executed the medication review. The appraised sample showed uncertain or high risk of bias in most of the items evaluated, resulting in low-quality studies. In comparison with usual care, pharmacist interventions were associated with significant reductions in HbA1c levels (-8.5% [95% CI: -1.06, -0.65]; P < 0.0001; I2 = 67.3%). Subgroup analysis indicated differences of heterogeneity by country, baseline HbA1c levels, setting, intervention frequency, and random allocation. Age and HbA1c levels partly explained the variability across studies by meta-regression.ConclusionsOur findings confirmed that pharmacist interventions improve glycemic control in patients with type 2 diabetes compared with usual care and suggest that younger patients or with higher baseline HbA1c levels may be the main beneficiaries of pharmacist care.Protocol PROSPERO Registration NumberCRD42014007457

Behavioural Lifestyle Intervention Study (BLIS) in patients with type 2 diabetes in the United Arab Emirates: A randomized controlled trial

Lifestyle modification is a cornerstone of the management of type 2 diabetes. However, in the United Arab Emirates, a country where type 2 diabetes is highly prevalent, non-compliance with a healthy lifestyle has been reported in many diabetic Emirati patients. The use of behavioural theories in lifestyle counselling is believed to facilitate behavioural changes, nevertheless, there are no published data regarding the use of structured behavioural lifestyle programmes tailored to suit Emirati culture. The primary objective of this study was to develop a behavioural lifestyle programme and to evaluate its effectiveness in improving glycaemic control in Emirati patients with type 2 diabetes. The Behavioural Lifestyle Intervention Study (BLIS) was a translational randomized controlled trial in which patients (n = 35) were randomly assigned to the intervention or control group. Patients in the intervention group went through a six-month behavioural lifestyle programme composed of 8 sessions, whereas patients in the control group received standard care. Cognitive behavioural theory was the underpinning theory for the lifestyle intervention. HbA1c levels were the trial’s primary outcome measure, and the main dietary factor targeted for change was carbohydrate intake. They were measured at baseline, 3 months and 6 months and were assessed using one-way ANOVA at a significance level of P < 0.05. All of the patients were then followed up at 1 year on all outcome measures. At 6 months, the HbA1c levels of the patients (n = 18) in the intervention group were significantly reduced (−1.56 ± 1.81, P < 0.05), whereas no significant change was observed in the patients of the control group. Similarly, both carbohydrate intake from cereals and total carbohydrate intake (in grams) were reduced (p < 0.05) in the intervention group, by 32.92 ± 54.34 and 20.94 ± 56.73, respectively. At 1 year, the patients in the intervention group maintained a significant reduction in HbA1c levels (−1.12 ± 1.46, p < 0.05), whereas no change was observed in the control group. The behavioural lifestyle intervention programme was effective in improving glycaemic control and compliance with carbohydrate intake goals in Emirati patients with type 2 diabetes. Larger randomized controlled trials are needed to validate these results and to identify key behavioural strategies that will improve compliance to lifestyle modifications in real life. Clinicaltrials.gov trial identifier NCT02386930

Effectiveness of peer support for improving glycaemic control in patients with type 2 diabetes: a meta-analysis of randomized controlled trials.

BackgroundTo assess the effects of peer support at improving glycemic control in patients with type 2 diabetes.MethodsRelevant electronic databases were sought for this investigation up to Dec 2014. Randomized controlled trials involving patients with type 2 diabetes that evaluated the effect of peer support on glycated hemoglobin (HbA1c) concentrations were included. The pooled mean differences (MD) between intervention and control groups with 95% confidence interval (CI) were calculated using random-effects model. The Cochrane Collaboration’s tool was used to assess the risk of bias.ResultsThirteen randomized controlled trials met the inclusion criteria. Peer support resulted in a significant reduction in HbA1c (MD −0.57 [95% CI: −0.78 to −0.36]). Programs with moderate or high frequency of contact showed a significant reduction in HbA1c levels (MD −0.52 [95% CI: −0.60 to −0.44] and −0.75 [95% CI: −1.21 to −0.29], respectively), whereas programs with low frequency of contact showed no significant reduction (MD −0.32 [95% CI: −0.74 to 0.09]). The reduction in HbA1c were greater among patients with a baseline HbA1c ≥ 8.5% (MD −0.78 [95% CI: −1.06 to −0.51]) and between 7.5 ~ 8.5% (MD −0.76 [95% CI: −1.05 to −0.47]), than patients with HbA1c < 7.5% (MD −0.08 [95% CI: −0.32 to 0.16]).ConclusionsPeer support had a significant impact on HbA1c levels among patients with type 2 diabetes. Priority should be given to programs with moderate or high frequency of contact for target patients with poor glycemic control rather than programs with low frequency of contact that target the overall population of patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-015-1798-y) contains supplementary material, which is available to authorized users.

Effects of a fixed-dose combination of sitagliptin and metformin versus respective monotherapies in newly diagnosed type 2 diabetic subjects

Metformin is considered as a backbone therapy for type 2 diabetes (T2DM) management. Many patients need treatment with combination therapy. In India, multiple fixed-dose combinations with metformin are available. The study was done to compare the efficacy and safety of sitagliptin plus metformin combination versus metformin and sitagliptin monotherapy in newly diagnosed T2DM subjects. This was an open-label, randomized, parallel group, prospective and single centre study, in 60 subjects with T2DM. The subjects received either metformin 500 mg, sitagliptin 50 mg or fixed-dose combination of metformin 500 mg plus sitagliptin 50 mg. All study medicines were given twice daily for 12 weeks. Glycaemic control (HbA1c, fasting and postprandial blood glucose) and body mass index (BMI) were evaluated as efficacy parameters while safety was evaluated by reporting adverse events. Significant reduction in HbA1C level was seen in all three groups (P = 0.0001). HbA1C reduction was significantly higher in the combination group compared to metformin monotherapy (P = 0.0072). Fasting blood glucose (FBG) level reduced significantly in all three groups (P = 0.0001). The reduction in fasting blood glucose was significantly higher with combination compared to sitagliptin monotherapy (P = 0.0060). Postprandial blood glucose (PPG) also reduced significantly in all three groups (P = 0.0001). The reduction with sitagliptin was statistically higher compared to metformin (P = 0.0155). The combination treatment resulted in significantly higher reduction of PPG compared to sitagliptin monotherapy (P = 0.0160). Body mass index reduced significantly in all three groups (P = 0.0001). Reduction in BMI was significant with combination treatment compared to sitagliptin monotherapy (P < 0.05). Overall, study medications were well tolerated. The incidence of adverse event was 11.7 %. No serious adverse event was reported in the study. In newly diagnosed, drug naive, type 2 diabetes mellitus management, fixed-dose combination of sitagliptin plus metformin is effective and well tolerated. Due to its multiple benefits, it can be used as a suitable option for selected subjects requiring combination therapy in type 2 diabetes mellitus.

Clinical Outcomes and Incremental Costs From a Medication Adherence Pilot Intervention Targeting Low-Income Patients With Diabetes at Risk of Cost-Related Medication Nonadherence

PurposeThe extent to which reducing cost-related barriers affects diabetes outcomes and medication adherence among uninsured patients is not known. The purpose of these analyses was to understand the clinical impact and cost considerations of a prescription assistance program targeting low-income, minority patients with diabetes and at high risk for cost-related medication nonadherence. MethodsPatients received diabetes medications without copayments for 12 months. Change in diabetes control was calculated by using glycosylated hemoglobin (HbA1c) level at follow-up compared with baseline. Clinical data were collected from the electronic health record. Medication adherence for diabetes medications was estimated by using proportion of days covered (PDC). Incremental acquisition and per-patient costs, based on actual hospital medication costs, were calculated for different baseline HbA1c levels. FindingsPatients with baseline HbA1c levels ≥7%, ≥8%, and ≥9% experienced mean HbA1c reductions of 0.82% (P = 0.008), 1.02% (P = 0.010), and 1.47% (P = 0.010), respectively, during the 12-month period. The average PDC was 70.55%; 45.24% had a PDC ≥80%, indicating an adequate level of medication adherence. Medication adherence ≥80% was associated with ethnicity (P = 0.015), whereas mean PDC was associated with number of diabetes medication classes used (P = 0.031). Acquisition cost for 1242 prescriptions filled by 103 patients was $13,365.82, representing per-patient costs of $132.39; however, as baseline targets increased, acquisition costs decreased and per-patient costs increased from $10,682.59 and $169.56 to $6509.91 and $192.27, respectively. ImplicationsClinically significant reductions in HbA1c levels were achieved for all patients, although greater reductions were achieved with modest per-patient cost increases when considering patients with uncontrolled diabetes. Incorporating a multifactorial intervention to address cost-related medication nonadherence with a behavior change component may yield greater reductions in HbA1c with improved diabetes outcomes and meaningful hospital-based cost savings.

Management of endocrine disease. Effects of telecare intervention on glycemic control in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

To review the published literature on the effects of telecare intervention in patients with type 2 diabetes and inadequate glycemic control. A review of randomized controlled trials on telecare intervention in patients with type 2 diabetes, and a search of electronic databases such as The Cochrane Library, PubMed, EBSCO, CINAHL, Science Direct, Journal of Telemedicine and Telecare, and China National Knowledge Infrastructure (CNKI), were conducted from December 8 to 16, 2013. Two evaluators independently selected and reviewed the eligible studies. Changes in HbA1c, fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), BMI, and body weight were analyzed. An analysis of 18 studies with 3798 subjects revealed that telecare significantly improved the management of diabetes. Mean HbA1c values were reduced by -0.54 (95% CI, -0.75 to -0.34; P<0.05), mean FPG levels by -9.00 mg/dl (95% CI, -17.36 to -0.64; P=0.03), and mean PPG levels reduced by -52.86 mg/dl (95% CI, -77.13 to -28.58; P<0.05) when compared with the group receiving standard care. Meta-regression and subgroup analyses indicated that study location, sample size, and treatment-monitoring techniques were the sources of heterogeneity. Patients monitored by telecare showed significant improvement in glycemic control in type 2 diabetes when compared with those monitored by routine follow-up. Significant reduction in HbA1c levels was associated with Asian populations, small sample size, and telecare, and with those patients with baseline HbA1c greater than 8.0%.

Indirect effects of decompression surgery on glycemic homeostasis in patients with Type 2 diabetes mellitus and lumbar spinal stenosis

Background contextLumbar spinal stenosis (LSS) patients with diabetes mellitus (DM) are presumed to experience difficulty when performing regular daily exercise, although such exercise is of paramount importance for glucose homeostasis and control. Therefore, decompression surgery, which can help patients perform regular physical activity, would have indirect positive effects on blood glucose control in LSS patients with DM. PurposeTo evaluate the indirect effects of spinal surgery on hemoglobin A1c (HbA1c) levels in the patient with Type 2 DM and LSS. Study designProspectively collected observational cohort data. Patient samplePatients with degenerative LSS and DM. Outcome measuresThe fasting total cholesterol (TC), fasting blood glucose (FBG), and HbA1c levels and visual analog scale (VAS) for back pain, VAS for leg pain, and Oswestry Disability Index (ODI). MethodsAccording to the treatment methods, 31 and 37 patients were allocated to the surgical and conservative treatment groups, respectively. The HbA1c, TC, and FBG levels and the ODI and VAS for back/leg pain were recorded for all patients before surgical and conservative treatments. At the first and second follow-up assessments after surgical or conservative treatment, the data were reassessed for all patients. ResultsIn both groups, the VAS for back/leg pain and the ODI scores significantly decreased after surgical or conservative treatment. In the surgical treatment group, the HbA1c levels were significantly decreased at the first and second assessments after surgery, whereas the conservative treatment group did not show significant reductions in HbA1c levels at the first and second follow-up assessments. In both groups, the FBG levels did not differ between the initial and follow-up assessments. The TC levels were significantly decreased at the second follow-up assessment, only in the surgical treatment group. The amount of ODI score reduction correlated positively with the degree of HbA1c level reduction at the first follow-up assessment. ConclusionsThe present study demonstrates the reduction in HbA1c level in patients with DM and LSS after decompression surgery with or without fusion. We believe this reduction in the HbA1c level may be a result of increased physical activity, subsequent to successful surgical decompression of the cauda equina.

Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

IntroductionHispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation.MethodsWe recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm.ResultsThe immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group.ConclusionThis home-based intervention delivered by CHWs was associated with a clinically and statistically significant reduction in HbA1c levels in Hispanic adults with HbA1c levels higher than 6%.

Use of Short Message Services (SMS) for the Management of Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Objectives. The primary objective is to determine if 3 times a week SMS will improve adherence to diet and exercise. The secondary objective is to determine the mean change in body weight, body mass index and glycosylated hemoglobin A1c (HbA1c). Methodology. This is an open-randomized controlled trial conducted for 6 months which included 104 subjects. Z test of two proportions was used to determine difference in dietary and exercise adherence. Mean change in body weight, BMI and HbA1c were also determined. After 3 months, significant difference is observed in mean HbA1c (SMS= 7.13 + 0.99, control= 7.53 + 0.91, p= 0.034). At 6 months, significant difference is seen in mean number of meals/day (SMS=2.61 + 0.63, control= 2.29 + 0.72, p= 0.018), mean number of minutes/exercise (SMS= 37.40 + 14.87, control=31.44 + 10.82, p= 0.021) and mean HbA1c (SMS=6.99 + 0.86, control= 7.34 + 0.90, p= 0.0452). Conclusion. The use of SMS as an adjunct to the standard of DM care improved adherence to diet after 6 months in terms of mean number of meals, improved adherence to exercise after 6 months in terms of mean number of minutes/exercise and significant reduction in HbA1c levels after 3 and 6 months.

Systematic review and meta-analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes

Diabetes mellitus is a chronic disease that necessitates continuing treatment and patient self-care education. Monitoring of blood glucose to near normal level without hypoglycemia becomes a challenge in the management of diabetes. Although self monitoring of blood glucose (SMBG) can provide daily monitoring of blood glucose level and help to adjust therapy, it cannot detect hypoglycemic unawareness and nocturnal hypoglycemia which occurred mostly in T1DM pediatrics. Continuous glucose monitoring (CGM) offers continuous glucose data every 5 minutes to adjust insulin therapy especially for T1DM patients and to monitor lifestyle intervention especially for T2DM patients by care providers or even patients themselves. The main objective of this study was to assess the effects of continuous glucose monitoring (CGM) on glycemic control in Type 1 diabetic pediatrics and Type 2 diabetic adults by collecting randomized controlled trials from MEDLINE (pubmed), SCOPUS, CINAHL, Web of Science and The Cochrane Library up to May 2013 and historical search through the reference lists of relevant articles. There are two types of CGM device: real-time CGM and retrospective CGM and both types of the device were included in the analysis. In T1DM pediatrics, CGM use was no more effective than SMBG in reducing HbA1c [mean difference – 0.13% (95% CI -0.38% to 0.11%,]. This effect was independent of HbA1c level at baseline. Subgroup analysis indicated that retrospective CGM was not superior to SMBG [mean difference -0.05% (95% CI -0.46% to 0.35%)]. In contrast, real-time CGM revealed better effect in lowering HbA1c level compared with SMBG [mean difference -0.18% (95% CI -0.35% to -0.02%, p = 0.02)]. In T2DM adults, significant reduction in HbA1c level was detected with CGM compared with SMBG [mean difference – 0.31% (95% CI -0.6% to -0.02%, p = 0.04)].This systematic review and meta-analysis suggested that real-time CGM can be more effective than SMBG in T1DM pediatrics, though retrospective CGM was not. CGM provided better glycemic control in T2DM adults compared with SMBG.

Efficacy, Safety, and Tolerability of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus: An Integrated Analysis of the DURATION Trials

Background and Aim: Exenatide is a glucagon-like peptide-1 receptor agonist demonstrated to improve glycemic control with low hypoglycemia risk in patients with type 2 diabetes mellitus. The Diabetes Therapy Utilization: Researching Changes in A1C, Weight, and Other Factors Through Intervention With Exenatide Once Weekly (DURATION) program comprised 6 randomized, comparator-controlled, 24- to 30-week trials of exenatide once weekly (EQW), an extended-release formulation. This post hoc analysis pooled data from patients taking EQW across 6 trials to assess efficacy and safety in a large, varied patient population. Materials and Methods: The intent-to-treat (ITT) population contained 1379 patients (baseline mean ± standard deviation glycated hemoglobin [HbA1c] levels of 8.4% ± 1.1%) who were treated with EQW over the course of 24 to 30 weeks. Changes from baseline in efficacy parameters for the ITT population and a completer population (1195 patients with ≥ 22 weeks of exposure) were evaluated. Results: The ITT population experienced significant reductions from baseline (least-squares mean [95% CI]) in HbA1c levels (−1.4% [−1.5% to −1.4%]), fasting blood glucose levels (−36 mg/dL [−38.4 mg/dL to −33.8 mg/dL]), and body weight (−2.5 kg [−2.8 kg to −2.3 kg]) after 24 to 30 weeks of EQW treatment. Reductions in HbA1c and fasting blood glucose levels were observed across baseline HbA1c, level strata; patients with higher baseline HbA1c levels experienced greater reductions. Treatment with EQW was associated with modest, significant reductions in blood pressure (systolic blood pressure, −2.8 mm Hg [−3.5 mm Hg to −2.1 mm Hg]; diastolic blood pressure, −0.8 mm Hg [−1.2 mm Hg to −0.4 mm Hg]), and fasting lipid levels (total cholesterol, −6.5 mg/dL [−8.2 mg/dL to −4.7 mg/dL]; low-density lipoprotein cholesterol, −3.9 mg/dL [5.3 mg/dL to −2.5 mg/dL]; and triglyceride [geometric least-squares mean percent change (95% CI)], −6% [−8% to −4%] levels). Similar reductions were observed in the completer population. Exenatide once weekly was generally well tolerated. Transient, mild-to-moderate gastrointestinal treatment-emergent adverse events and injection-site treatment-emergent adverse events were reported most frequently, but were seldom treatment limiting. No major hypoglycemic events were observed; minor hypoglycemic events occurred infrequently in patients not using a sulfonylurea. Conclusion: This post hoc analysis of > 1300 patients demonstrated that EQW was associated with significant reductions in HbA1c levels, body weight, blood pressure, and fasting lipid levels, with minimal hypoglycemia risk. Consistent with established safety profiles, EQW therapy was generally well tolerated., Trial registration: www.ClinicalTrials.gov identifiers: NCT00308139, NCT00637273, NCT00641056, NCT00676338, NCT00877890, NCT01029886

Impact of lifestyle modification on glycemic control in patients with type 2 diabetes mellitus

Background:Current treatment guidelines support the role of lifestyle modification, in terms of increasing the quantity and quality of physical activity to achieve target glycemia in patients with type 2 diabetes mellitus.Objective:To assess the effect of structured exercise training and unstructured physical activity interventions on glycemic control.Materials and Methods:This was a randomized six-month exercise intervention study conducted with previously inactive 279 patients of type 2 diabetes mellitus. Before randomization, all enrolled T2DM participants (n: 300; 30 to 60 year old, having diabetes for more than a year with HbA1c levels of 6.5% or higher) entered a one-month run-in phase to reduce dropout and maintain adherence.Results:A recommendation to increase physical activity was beneficial (0.14% HbA1c reduction; P = 0.12), but was not bringing significantly declines in HbA1c, whereas, structured exercise training is associated with a significant HbA1c decline of 0.59%. (P = 0.030). In a subgroup analysis limited to participants with a baseline HbA1c value > 7%, both the unstructured (0. 48%; P = 0.04) and structured exercise training (0.77%; P < 0.01) groups experienced significant decline in HbA1c Vs the control, whereas among participants with baseline hemoglobin A1c values less than 7%, significant reduction occurred only in the structured exercise training group. Changes in blood pressure; total cholesterol, HDL-cholesterol (high-density lipoprotein), LDL-cholesterol (low-density lipoprotein) and the atherogenic index factors did not statistically significantly differ within (baseline to follow-up) and among groups.Conclusion:Supervised structured training was more efficacious than unstructured activity in achieving declines in HbA1c. Although both structured and unstructured training provide benefits, only the former was associated with significant reductions in HbA1c levels. Therefore, T2DM patients should be stimulated to participate in specifically designed exercise intervention programs.