Weight change upon once‐daily initiation of insulin detemir with or without dietary intervention in overweight or obese insulin‐naïve individuals with type 2 diabetes: results from the DIET trial

Abstract

Aims: Weight gain upon insulin initiation is opposite to clinical goals in diabetes management. This trial aimed to determine the impact of modest dietary intervention on weight change and examine weight change in baseline body mass index strata when initiating once-daily insulin detemir (IDet) in overweight or obese insulin-naïve individuals with type 2 diabetes (T2D).Methods: DIET (Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes) was a 26-week, randomized, treat-totarget, stratified, controlled, open-label, multinational trial. Subjects were randomized 1 : 1 to either the IDet group, which received basic dietary and physical exercise advice at baseline, or the Diet+IDet group, which had additional dietary consultations with a certified dietician (three face-to-face meetings, three phone contacts).Results: Mean estimated change in body weight from baseline ± standard error (SE) was −1.05 ± 0.23 kg for Diet+IDet and −0.56 ± 0.23 kg for IDet alone. Estimated mean difference was 0.49 kg (95% confidence interval: −0.15; 1.13, p = 0.132). Glycaemic control, measured by haemoglobin A1c (HbA1c) and fasting plasma glucose, improved similarly in both groups. Both groups reported variable reductions in caloric intake and overall physical activity levels. No difference in hypoglycaemia rates between groups was observed. Conclusion:This study suggests that a modest dietary intervention plus basic lifestyle advice, compared with basic lifestyle advice alone, resulted in similar weight change, efficacy, safety and tolerability when initiating IDet once daily in overweight or obese insulin-naïve individuals with T2D.

Quality of development and reporting of dietetic intervention studies in primary care: a systematic review of randomised controlled trials

“…Twenty‐seven RCTs met the eligibility criteria and were included in the review, as shown in Figure .…”

Effectiveness of Dietetic Consultations in Primary Health Care: A Systematic Review of Randomized Controlled Trials

“…22 Social Science Statistics online tool for paired sample t-test 23 was used to calculate the p-value within each study group for studies not reporting the mean difference over time. 20,21,[24][25][26][27][28] Where studies did not report the between group differences, mean difference (with SD) and p-value between the intervention and comparison for each study was calculated using Open Source Epidemiologic Statistics for Public Health' (Version 3.03a) online tool. 29 A statistically significant betweengroup difference was used to indicate intervention effectiveness for dietary intake, anthropometric measurements and clinical indicators (significance level was set at p<0.05).…”

“…After excluding duplicate copies of articles, the main reasons for excluding publications were due to a non-RCT study design (n=3925) or not an eligible dietetic intervention (n=334), as outlined in Figure 2, leaving 26 RCTs eligible for inclusion. 20,21,[24][25][26][27][28][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49] For each of the six included studies with multiple intervention arms, two arms (intervention and control) met the inclusion criteria, while the third arm did not. 20,27,36,37,44,45 Only data from applicable arms were extracted for data tables.…”

“…Most studies were conducted in single site outpatient primary health care settings and recruited individuals with at least one risk factor for chronic disease (such as high BMI or high serum cholesterol), or with a diagnosis of a health condition (such as HIV, peripheral vascular disease or Type 2 Diabetes mellitus). Most studies were conducted in North America (nine studies) 21,24,25,28,32,38,41,43,46 or the United Kingdom/Europe (seven studies), 27,39,40,42,44,45,47 with fewer from Australia/New Zealand (three studies), 20,34,37 Asia (five studies), 26,35,36,48,49 the Middle East (one study), 33 and South America (one study). 31 The 26 studies contributed baseline measures for 5500 adults (median n=86).…”

“…Comparison groups included control groups receiving no intervention (10 studies); 20,26,27,31,39,40,42,45,47,48 usual care including medical care that did not include nutrition care from any health professional (nine studies); 24,32,33,35,36,38,41,43,49 or minimal care including attendance at a single general nutrition session or provision of a diet sheet (seven studies). 21,25,28,34,37,44,46…”