Metabolic effects of Dapagliflozin in patients with diabetes mellitus
Research type
Research Study
Full title
Exploring appetitive, metabolic and ketotic effects and weight-loss potential of Dapagliflozin in patients with Type 2 Diabetes Mellitus and inadequate glycaemic control, with concomitant dietary intervention
IRAS ID
229929
Contact name
Thomas M Barber
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
Background: Type 2 Diabetes Mellitus (T2D) is closely associated with weight-gain and obesity. Weight-loss is a key strategy for most patients with T2D (in whom the vast majority are overweight). Unfortunately, traditional therapies for T2D (such as sulphonylureas and insulin) promote weight-gain, which further worsens metabolic aberrations. It is well-established that weight-loss in patients with T2D is associated with improved blood sugar control, and also improves general metabolic health. Dapagliflozin, the first-in-class of the Sodium Glucose-Like Transporter 2 (SGLT2) inhibitor agents, licensed for use in patients with T2D, has been demonstrated both on evidence from randomized controlled trials and real-world studies, to be associated with secondary weight-loss.
Aim/rationale: There have been relatively few studies exploring the metabolic effects of Dapagliflozin and how they relate to weight loss. The aim of our study is to undertake a detailed assessment of the appetitive and metabolic effects of Dapagliflozin and how these relate to body fat, insulin resistance, glycaemia and other metabolic parameters in fully-consented patients with T2D with inadequate blood sugar control.
Methodology: The metabolic studies will take place in a Human Metabolic Unit housed within the University Hospitals of Coventry and Warwickshire (UHCW) NHS site.We plan to recruit adult human participants who attend hospital clinics held at the UHCW. Initial investigation will include measurements of height, weight, fat mass (bioimpedance technology) and blood pressure. We will also take blood samples for storage of plasma and serum (for assay of endocrine and metabolic indices) and urine samples. Participants will undergo detailed metabolic studies to include indirect calorimetry (energy expenditure measurements) and quantification of body fat. Sleep quality will also be assessed (through use of well validated portable machines) during calorimetry. We plan to use magnetic resonance imaging to assess brown fat distribution (a type of fat involved in heat generation and energy expenditure).REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0330
Date of REC Opinion
19 Sep 2017
REC opinion
Further Information Favourable Opinion