GLP-1 agonism with VLCD

  • Research type

    Research Study

  • Full title

    The anabolic effects of GLP-1 agonism to prevent lean muscle losses during very-low calorie diets (VLCDs) for weight loss

  • IRAS ID

    297489

  • Contact name

    Iskandar Idris

  • Contact email

    iskandar.idris@nottingham.ac.uk

  • Sponsor organisation

    University of Nottingham

  • Clinicaltrials.gov Identifier

    NCT05606471

  • Duration of Study in the UK

    1 years, 11 months, 27 days

  • Research summary

    The very-low calorie diet (VLCD) is highly effective for inducing significant weight loss and substantial improvements in blood glucose levels in people with type 2 diabetes (T2D) living with obesity. A recent series of studies found that VLCD can even induce remission of T2D, and these positive results have led to VLCD being adopted by the NHS as a treatment for T2D in people with obesity.

    Unfortunately, weight regain and worsening of diabetes control (leading to relapse of diabetes in those that achieved remission) following VLCD cessation is common, limiting their long-term effectiveness. Furthermore, concerns exist about the amount of skeletal muscle (SM) mass lost during VLCD, accounting for 20-30% of total weight loss. SM is crucial for controlling blood glucose levels and reduced SM mass is linked to higher insulin resistance, and worse glycaemic control. Thus, in the context of weight regain after VLCD, lower SM mass could cause worse diabetes in the long term. Therefore, a way to reduce SM loss during VLCD could be critical to improving the long term effectiveness of VLCD.

    Glucagon-like peptide-1 (GLP-1) agonists are medications used to help people with T2D lose weight and improve blood glucose control. Recently, our department showed that the GLP-1 hormone also stimulates SM growth at low levels. Therefore, a GLP-1 agonist could help reduce SM loss if given alongside a VLCD.

    The aim of this physiological study is to test this hypothesis by investigating the effect of the GLP-1 agonist Semaglutide on SM turnover, and whether it reduces the loss of SM induced by VLCD. Forty-five people with T2D will receive either Semaglutide only, VLCD only, or both Semaglutide & VLCD, for 12 weeks. Measures of SM turnover, SM mass, body composition and insulin sensitivity will be taken at baseline and during the 12-week intervention period.

  • REC name

    East of England - Essex Research Ethics Committee

  • REC reference

    21/EE/0163

  • Date of REC Opinion

    11 Aug 2021

  • REC opinion

    Further Information Favourable Opinion