Abstract
Aims/hypothesisSubstantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication. The Diabetes Remission Clinical Trial (DiRECT), a cluster-randomised controlled trial, is testing a structured intervention designed to achieve and sustain this over 2 years in a primary care setting to determine practicability for routine clinical practice. This paper reports the characteristics of the baseline cohort.MethodsPeople with type 2 diabetes for <6 years with a BMI of 27–45 kg/m2 were recruited in 49 UK primary care practices, randomised to either best-practice diabetes care alone or with an additional evidence-based weight management programme (Counterweight-Plus). The co-primary outcomes, at 12 months, are weight loss ≥15 kg and diabetes remission (HbA1c <48 mmol/mol [6.5%]) without glucose-lowering therapy for at least 2 months. Outcome assessors are blinded to group assignment.ResultsOf 1510 people invited, 423 (28%) accepted; of whom, 306 (72%) were eligible at screening and gave informed consent. Seven participants were later found to have been randomised in error and one withdrew consent, leaving 298 (176 men, 122 women) who will form the intention to treat (ITT) population for analysis. Mean (SD) age was 54.4 (7.6) years, duration of diabetes 3.0 (1.7) years, BMI 34.6 (4.4) kg/m2 for all participants (34.2 (4.2) kg/m2 in men and 35.3 (4.6) kg/m2 in women) and baseline HbA1c (on treatment) 59.3 (12.7) mmol/mol (7.6% [1.2%]). The recruitment rate in the intervention and control groups, and comparisons between the subgroups recruited in Scotland and England, showed few differences.Conclusions/interpretationDiRECT has recruited a cohort of people with type 2 diabetes with characteristics similar to those seen in routine practice, indicating potential widespread applicability. Over 25% of the eligible population wished to participate in the study, including a high proportion of men, in line with the prevalence distribution of type 2 diabetes.Trial registrationwww.controlled-trials.com/ISRCTN03267836; date of registration 20 December 2013
Highlights
Aims/hypothesis Substantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication
The Diabetes Remission Clinical Trial was designed to answer a series of linked questions [10]: What proportion of the whole population with type 2 diabetes would agree to undertake substantial weight loss? How many of these could achieve ≥15 kg weight loss and return to non-diabetic blood glucose control off medication at 1 year? What happens to the major pathophysiological factors underlying type 2 diabetes during continued follow up? What are the psychological consequences of the programme and can outcomes be predicted by psychometric variables? What proportion of the intervention group remains non-diabetic after 2 years? This paper describes the recruitment process, outcomes of recruitment and baseline characteristics of the study participants
Certain inclusion criteria were applied for recruitment into Diabetes Remission Clinical Trial (DiRECT) for various
Summary
People with type 2 diabetes for
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