The safety and efficacy of a low-energy diet to induce weight loss, improve metabolic health, and induce diabetes remission in insulin-treated obese men with type 2 diabetes: a pilot RCT

Willem Frederik Mollentze,Annette Prins,Sonelle Van Der Linde,Kelebogile Gloria Tsie,Gertruida Martha Marx,Georgina Joubert

doi:10.1007/s13410-019-00734-1

Willem Frederik Mollentze, Annette Prins + Show 4 more

Open Access

https://doi.org/10.1007/s13410-019-00734-1

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Abstract

BackgroundData are sparse on the safety and efficacy of commercially available energy-restricted meal plans in obese subjects with type 2 diabetes mellitus (T2DM). This study examined the safety and efficacy of a commercially available low-energy diet in insulin-treated obese men with type 2 diabetes.MethodsEighteen men ≥ 35 years old who had class III obesity, had received insulin treatment for ≥ 1 year for type 2 diabetes, and had glycated hemoglobin (Hb) ≥ 6.5% were randomized to receive either a low-energy diet (N = 9) or standard medical nutrition intervention (N = 9) for 6 months.ResultsCompared with 1.5% (± 3.55) in the control group, the mean percentage weight loss in the intervention group at 6 months was 9.6% (±4.91) (p < 0.01). Complete and partial diabetes remission occurred in one subject each in the intervention group and no subjects in the control group. Mean glycated Hb levels were 8.9% (± 2.76) and 9.1% (± 1.53) (p = NS) at baseline and 6.5% (± 0.64) and 7.4% (± 1.12) (p = 0.0606) at 6 months for the intervention and control groups, respectively. Compared with 0.85 mmol/L at baseline, the mean high-density lipoprotein cholesterol (HDL-C) level in the intervention group at 6 months increased to 0.96 mmol/L (p < 0.01) while it remained unchanged in the control group.ConclusionsAmong obese men with insulin-treated type 2 diabetes, compared with standard medical nutrition, 6 months of a low-energy diet resulted in complete diabetes remission in one subject and partial remission in another while improving diabetes control and decreasing the median daily dose of insulin in the remainder.

Highlights

Data are sparse on the safety and efficacy of commercially available energy-restricted meal plans in obese subjects with type 2 diabetes mellitus (T2DM)
At 3 and 6 months, subjects in the intervention group achieved a mean reduction in body weight (BW) from baseline of 9.0% (± 3.55) (11.6 kg) and 9.6% (± 4.91) (12.6 kg) respectively, compared to 1.9% (± 2.25) (2.6 kg) and 1.5% (± 3.55) (0.6 kg) in control subjects at corresponding time points (p < 0.01 for both between-group comparisons) (Table 2)
Complete and partial remission of diabetes occurred in one subject each in the intervention group compared to none in the control group

Summary

Introduction

Data are sparse on the safety and efficacy of commercially available energy-restricted meal plans in obese subjects with type 2 diabetes mellitus (T2DM). This study examined the safety and efficacy of a commercially available low-energy diet in insulin-treated obese men with type 2 diabetes. Results Compared with 1.5% (± 3.55) in the control group, the mean percentage weight loss in the intervention group at 6 months was 9.6% (±4.91) (p < 0.01). Current guidelines advocate very low-calorie diets (VLCD) in obese subjects with T2DM to achieve weight loss greater than 5% in 3 months only under close medical supervision [4]. The data supporting these recommendations are limited [5, 6]. After 6 months, the responders lost 15.4% of their body weight and were still in remission indicating that T2DM is potentially reversible by substantial weight loss

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