Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial

Abstract

IntroductionPeople with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.Methods and analysisThis study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m2and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends.Ethics and disseminationEthical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.Trial registration numberISRCTN18399564.

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“…However, a longer intervention control and data registration could provide new insight on efficacy of this program. We are conscious that a benefit on other diseases, such as cardiovascular risk factors, or diabetes is probably seen with a BMI decrease in the range of 5-10%, being considered as secondary objective in a large randomized trial for adults with a recent diagnosis of type 2 diabetes [45], but it remains unclear whether a BMI decrease less than 5% can impact on BC prognosis…”

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“…Diabetes is characterized by weight loss due to deficiencies in glucose metabolism and overdepletion of histamine. 39 After 4 weeks of treatment, the weight of mice in the MET and GDPH groups was significantly different from that in the MD group; the weight loss trend slowed, and the weight gradually increased in the later stage (Figure 3A). As shown in Figure 3B, at week 0, the FBG of the mice in the MD group was significantly higher than that in the NM group (p < 0.05) and was higher than 11.1 mmol/L, indicating the successful modeling of T2DM.…”

“…Diabetes is characterized by weight loss due to deficiencies in glucose metabolism and overdepletion of histamine . After 4 weeks of treatment, the weight of mice in the MET and GDPH groups was significantly different from that in the MD group; the weight loss trend slowed, and the weight gradually increased in the later stage (Figure A).…”