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Participant experiences in the Diabetes REmission Clinical Trial (DiRECT).
Rehackova, L, Rodrigues, AM, Thom, G, Brosnahan, N, Barnes, AC, McCombie, L, Leslie, WS, Zhyzhneuskaya, S, Peters, C, Adamson, AJ, et al
Diabetic medicine : a journal of the British Diabetic Association. 2022;(1):e14689
Abstract
INTRODUCTION The Diabetes REmission Clinical Trial (DiRECT) has shown that sustained remission of type 2 diabetes in primary care is achievable through weight loss using total diet replacement (TDR) with continued behavioural support. Understanding participants' experiences can help optimise the intervention, support implementation into healthcare, and understand the process of behaviour change. METHODS Thirty-four DiRECT participants were recruited into this embedded qualitative evaluation study. In-person and telephone interviews were conducted before the TDR; at week 6-8 of the TDR; 2 weeks into food reintroduction (FR); and at 1 year, to learn about participant experiences with the programme. Transcribed narratives were analysed thematically, and we used interpretation to develop overarching themes. RESULTS Initiation of the TDR and transition to FR were challenging and required increased behavioural support. In general, adhering to TDR proved easier than the participants had anticipated. Some participants chose the optional extension of TDR. Rapid weight loss and changes in diabetes markers provided ongoing motivation. Further weight loss, behavioural support and occasional use of TDR facilitated weight loss maintenance (WLM). A process of behaviour adaptation to change following regime disruption was identified in three stages: (1) expectations of the new, (2) overcoming difficulties with adherence, and (3) acceptance of continuous effort and establishment of routines. CONCLUSIONS The DiRECT intervention was acceptable and regularity, continuity, and tailoring of behavioural support was instrumental in its implementation in primary care. The adaptation process accounts for some of the individual variability of experiences with the intervention and highlights the need for programme flexibility.
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Predictors of type 2 diabetes remission in the Diabetes Remission Clinical Trial (DiRECT).
Thom, G, Messow, CM, Leslie, WS, Barnes, AC, Brosnahan, N, McCombie, L, Al-Mrabeh, A, Zhyzhneuskaya, S, Welsh, P, Sattar, N, et al
Diabetic medicine : a journal of the British Diabetic Association. 2021;(8):e14395
Abstract
AIM: To identify predictors of type 2 diabetes remission in the intervention arm of DiRECT (Diabetes Remission Clinical Trial). METHODS Participants were aged 20-65 years, with type 2 diabetes duration of <6 years and BMI 27-45 kg/m2 , and were not receiving insulin. Weight loss was initiated by total diet replacement (825-853 kcal/day, 3-5 months, shakes/soups), and weight loss maintenance support was provided for 2 years. Remissions (HbA1c <48 mmol/mol [<6.5%], without antidiabetes medications) in the intervention group (n = 149, mean age 53 years, BMI 35 kg/m2 ) were achieved by 68/149 participants (46%) at 12 months and by 53/149 participants (36%) at 24 months. Potential predictors were examined by logistic regression analyses, with adjustments for weight loss and effects independent of weight loss. RESULTS Baseline predictors of remission at 12 and 24 months included being prescribed fewer antidiabetes medications, having lower triglyceride and gamma-glutamyl transferase levels, and reporting better quality of life with less anxiety/depression. Lower baseline HbA1c was a predictor at 12 months, and older age and male sex were predictors at 24 months. Being prescribed antidepressants predicted non-remission. Some, but not all effects were explained by weight loss. Weight loss was the strongest predictor of remission at 12 months (adjusted odds ratio per kg weight loss 1.24, 95% CI 1.14, 1.34; P < 0.0001) and 24 months (adjusted odds ratio 1.23, 95% CI 1.13, 1.35; P <0.0001). Weight loss in kilograms and percentage weight loss were equally good predictors. Early weight loss and higher programme attendance predicted more remissions. Baseline BMI, fasting insulin, fasting C-peptide and diabetes duration did not predict remission. CONCLUSIONS Other than weight loss, most predictors were modest, and not sufficient to identify subgroups for which remission was not a worthwhile target.
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Time Course of Normalization of Functional β-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes.
Zhyzhneuskaya, SV, Al-Mrabeh, A, Peters, C, Barnes, A, Aribisala, B, Hollingsworth, KG, McConnachie, A, Sattar, N, Lean, MEJ, Taylor, R
Diabetes care. 2020;(4):813-820
Abstract
OBJECTIVE To assess functional β-cell capacity in type 2 diabetes during 2 years of remission induced by dietary weight loss. RESEARCH DESIGN AND METHODS A Stepped Insulin Secretion Test with Arginine was used to quantify functional β-cell capacity by hyperglycemia and arginine stimulation. Thirty-nine of 57 participants initially achieved remission (HbA1c <6.5% [<48 mmol/mol] and fasting plasma glucose <7 mmol/L on no antidiabetic drug therapy) with a 16.4 ± 7.7 kg weight loss and were followed up with supportive advice on avoidance of weight regain. At 2 years, 20 participants remained in remission in the study. A nondiabetic control (NDC) group, matched for age, sex, and weight after weight loss with the intervention group, was studied once. RESULTS During remission, median (interquartile range) maximal rate of insulin secretion increased from 581 (480-811) pmol/min/m2 at baseline to 736 (542-998) pmol/min/m2 at 5 months, 942 (565-1,240) pmol/min/m2 at 12 months (P = 0.028 from baseline), and 936 (635-1,435) pmol/min/m2 at 24 months (P = 0.023 from baseline; n = 20 of 39 of those initially in remission). This was comparable to the NDC group (1,016 [857-1,507] pmol/min/m2) by 12 (P = 0.064) and 24 (P = 0.244) months. Median first-phase insulin response increased from baseline to 5 months (42 [4-67] to 107 [59-163] pmol/min/m2; P < 0.0001) and then remained stable at 12 and 24 months (110 [59-201] and 125 [65-166] pmol/min/m2, respectively; P < 0.0001 vs. baseline) but lower than that of the NDC group (250 [226-429] pmol/min/m2; P < 0.0001). CONCLUSIONS A gradual increase in assessed functional β-cell capacity occurred after weight loss, becoming similar to that of NDC group participants by 12 months. This result was unchanged at 2 years with continuing remission of type 2 diabetes.
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Views, experience and adherence among pregnant women with gestational diabetes participating in a weight loss study (WELLBABE).
McParlin, C, Hodson, K, Barnes, AC, Taylor, R, Robson, SC, Araujo-Soares, V
Diabetic medicine : a journal of the British Diabetic Association. 2019;(2):195-202
Abstract
AIMS: To investigate the views and experience of pregnant women newly diagnosed with gestational diabetes mellitus participating in a 1200 kcal/day diet to achieve moderate weight loss (the WELLBABE study), and to explore barriers to and facilitators of adherence. METHODS Twelve participants engaged in semi-structured interviews after completion of the 4-week diet. An interview schedule was devised using open-ended questions guided by the Theoretical Domains Framework. Transcript responses were analysed thematically. RESULTS Participants were anxious about their diagnosis of gestational diabetes, but concerns related to dieting in pregnancy were allayed by reassurance from the research team. Participants expected health benefits, improved knowledge and support from enrolling on the study. The participants' primary motivator to diet adherence was their baby's wellbeing. Other facilitatory factors included improving their own health and reducing any future risk of diabetes. Trying to provide reliable results and receiving extra care also facilitated adherence. Partners, friends and family were an important source of social support and no barrier caused by concern about weight loss in pregnancy was encountered. Observed and experienced physical changes and feedback from the research team positively reinforced adherence. The main barrier was that learning new skills was initially time-consuming. CONCLUSIONS Weight loss was acceptable to women with gestational diabetes provided with clear information about likely benefit. A randomized controlled trial of this intervention is now required, employing clear information and feedback of glycaemic benefit to facilitate efficacy.
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Weight losses with low-energy formula diets in obese patients with and without type 2 diabetes: systematic review and meta-analysis.
Leslie, WS, Taylor, R, Harris, L, Lean, ME
International journal of obesity (2005). 2017;(1):96-101
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Abstract
AIM: To provide a systematic review, of published data, to compare weight losses following very low calorie (<800 kcal per day VLCD) or low-energy liquid-formula (>800 kcal per day LELD) diets, in people with and without type 2 diabetes mellitus (T2DM). METHODS Systematic electronic searches of Medline (1946-2015) and Embase (1947-2015) to identify published studies using formula total diet replacement diets (VLCD/LELD). Random effects meta-analysis using weighted mean difference (WMD) in body weight between groups (with and without diabetes) as the summary estimate. RESULTS Final weight loss, in the five included studies, weighted for study sizes, (n=569, mean BMI=35.5-42.6 kg/m2), was not significantly different between participants with and without T2DM: -1.2 kg; 95% CI: -4.1 to 1.6 kg). Rates of weight loss were also similar in the two groups -0.6 kg per week (T2DM) and 0.5 kg per week (no diabetes), and for VLCD (<800 kcal per day) and LELD (>800 kcal per day). CONCLUSIONS Weight losses with liquid-formula diets are very similar for VLCD and LELD and for obese subjects with or without T2DM. They can potentially achieve new weight loss/ maintenance targets of >15-20% for people with severe and medically complicated obesity.