Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets (SemVLCD)
Type 2 Diabetes Mellitus in Obese
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus in Obese focused on measuring Type 2 diabetes, Obesity, GLP-1, Semaglutide, VLCD
Eligibility Criteria
Inclusion Criteria: Confirmed Type 2 Diabetes Mellitus Body mass index > 27kg·m-2 Eligible for VLCD, Semaglutide (or both), within routine practice Ability to provide informed consent Exclusion Criteria: BMI > 50kg·m-2 Current pregnancy or breastfeeding, or intention to fall pregnant within the next 3 months Uncontrolled hypertension (blood pressure >200/120mmHg) Current treatment with insulin Current or recent use of GLP-1 agonists Previous adverse reaction to a GLP-1 agonist Current or recent involvement in a VLCD programme (within the last 12 months) History of >5% weight loss within the preceding 12 months Ingestion of exogenous D2O within the preceding 12 months Background of clinically significant cardiovascular, cerebrovascular or respiratory disease, neurological disorders or musculoskeletal problems History of malignancy undergoing current treatment or palliation History of any medical condition contraindicating the use of GLP-1 agonist medication Any other medical condition deemed by the investigators to preclude inclusion into the study
Sites / Locations
- University of Nottingham, Royal Derby Hospital CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
VLCD only
Semaglutide only
Combined VLCD plus Semaglutide
Participants in this group will be placed on a very-low calorie diet with a daily energy intake limit of 800 kilocalories. 600 kilocalories will be made up of total meal replacement products supplied by Lighterlife UK. The remaining 200 kilocalories will be flexible for participants to add additional vegetables to supplement the total meal replacement products, allowing some variety to the diet.
Participants will be asked to self-administer the GLP-1 agonist Semaglutide weekly, as per clinical practice. They will be asked to start at 0.25mg and increase every two weeks (if tolerated) to the maintenance dose of 1mg, which they will continue until the end of the study.
Participants in this group will both partake in the VLCD, and take the weekly dose of Semaglutide (as described above).