Objectives The management of patients with long-standing type 2 diabetes and obesity receiving insulin therapy (IT) is a substantial clinical challenge. Our objective was to examine the effect of a low-energy total diet replacement (TDR) intervention versus standardized dietetic care in patients with long-standing type 2 diabetes and obesity receiving IT.
Research design and methods In a prospective randomized controlled trial, 90 participants with type 2 diabetes and obesity receiving IT were assigned to either a low-energy TDR (intervention) or standardized dietetic care (control) in an outpatient setting. The primary outcome was weight loss at 12 months with secondary outcomes including glycemic control, insulin burden and quality of life (QoL).
Results Mean weight loss at 12 months was 9.8 kg (SD 4.9) in the intervention and 5.6 kg (SD 6.1) in the control group (adjusted mean difference −4.3 kg, 95% CI −6.3 to 2.3, p<0.001). IT was discontinued in 39.4% of the intervention group compared with 5.6% of the control group among completers. Insulin requirements fell by 47.3 units (SD 36.4) in the intervention compared with 33.3 units (SD 52.9) in the control (−18.6 units, 95% CI −29.2 to –7.9, p=0.001). Glycated Hemoglobin (HbA1c) fell significantly in the intervention group (4.7 mmol/mol; p=0.02). QoL improved in the intervention group of 11.1 points (SD 21.8) compared with 0.71 points (SD 19.4) in the control (8.6 points, 95% CI 2.0 to 15.2, p=0.01).
Conclusions Patients with advanced type 2 diabetes and obesity receiving IT achieved greater weight loss using a TDR intervention while also reducing or stopping IT and improving glycemic control and QoL. The TDR approach is a safe treatment option in this challenging patient group but requires maintenance support for long-term success.
Trial registration number ISRCTN21335883.
- low calorie diet
- type 2 diabetes
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Contributors All authors contributed to the design of the study. AB coordinated and undertook the recruitment. AB, AD and BM undertook the study. AB coordinated the laboratory analysis. OO undertook the statistical analysis. GSF is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the writing of the manuscript. All authors reviewed the manuscript and approved the final version.
Funding This article presents independent investigator research supported by an educational gift from Cambridge Weight Plan and the National Institute of Health Research (NIHR) Clinical Research Facility at Imperial College Healthcare NHS Trust. The Section for Nutrition Research is funded by grants from the UK Medical Research Council (MRC) and BBSRC and is supported by the NIHR Imperial Biomedical Research Centre (BRC) funding scheme. ST is funded by the Biomedical Research Program at Weill Cornell Medicine in Qatar, supported by Qatar Foundation. ST also receives funding from the Qatar National Research Fund (grant NPRP 8-912-3-19). GSF is an NIHR senior investigator. The formula product was donated by Cambridge Weight Plan who did not have any input into data analysis or interpretation.
Disclaimer The views expressed are those of the authors and not necessarily those of the BBSRC, the NHS, the NIHR or the Department of Health.
Competing interests AB, GSF and ST received funding for investigator-initiated research through an educational grant from Cambridge Weight Plan. ST serves on advisory boards for Novo Nordisk. All the authors received no financial benefit. AB has received travel grants and conference fees from Cambridge Weight Plan. BM serves on advisory boards for Novo Nordisk and Boehringer Ingelheim, received educational fees from Novo Nordisk, Lilly, Boehringer Ingelheim and Ethicon, and research grants from Novo Nordisk. ARL was previously employed as medical director at Cambridge Weight Plan but held no shares personally. ARL is also the chairman of Total Diet Meal Replacement Europe.
Patient consent for publication Not required.
Ethics approval The trial was registered prior to recruitment on the ISRCTN registry and approved by the local and national regulatory agencies (Ref: 12/WM/0199).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Deidentified participant data that underlie the results reported in this article will be made available beginning 12 months and ending 5 years after publication. Proposals should be made to the corresponding author and will require a data access agreement.