Abstract

Background/Aim. Gastric contraction modulation (GCM) with the implanted DIAMOND device improves glycemic control and decreases weight. The main aim of this study was to evaluate the early efficacy of GCM using the DIAMOND (previously named TANTALUS) System in the improvement of glycemic control measured by changes in glycosylated hemoglobin (HbA1c). The effects of GCM on weight loss, body mass index (BMI), reduction of the waist circumference and metabolic parameters other than HbA1c were also evaluated. Methods. A total of 18 adult patients with type 2 diabetes were surgically treated at the Department for Minimally Invasive Upper Digestive Surgery, Clinic for Digestive Surgery in Belgrade, Serbia, using gastric pacemaker (DIAMOND System) from November 2014 to March 2016. Out of the total number of patients, 11 finished week 16 visit and were enroled in this prospective cohort study. Results. During the observed period, the average weight loss amounted to 8.05 kg (p < 0.05). The average difference between the baseline fasting glucose level and the level after 16 weeks period is 2.56 mmol/L. Similar findings were noted in fasting insulin levels, with an average decrease of 6.44 m/U/L after 16 weeks. The majority of patients experienced a decrease in HbA1c value: in 4 patients higher than 2%, and in 4 patients up to 2% (p < 0.05). Lower level of fasting insulin with simultaneous decrease in fasting glucose indicates improvement in insulin sensitivity on week 16 [homeostatic model assessment of insulin resistance (HOMA IR) average 5.25]. Conclusion. Gastric stimulation using the DIAMOND System for 16 weeks causes significant early improvement in glycemic control and insulin resistance. There is an additional positive effect on weight loss, body mass index (BMI) and reduction of the waist circumference as a main parameter of the metabolic syndrome.

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