Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets

Sponsor
University of Nottingham
Study ID
NCT05606471
Phase
PHASE4
Status
Unknown

Conditions

  • Type 2 Diabetes Mellitus in Obese

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pen Injector [Ozempic] — DRUG
    Glucagon-like peptide 1 (GLP-1) receptor agonist
  • Very-low Calorie Diet — DIETARY_SUPPLEMENT
    Total meal replacement with a limit of 800 kilocalories per day

Study Details

The very-low calorie diet (VLCD) is a highly effective and safe way to rapidly lose significant amounts of weight and dramatically improve blood sugar control in a short period of time (typically 8-12 weeks). It has recently become recommended by the UK National Health Service as a treatment for selected patients with type 2 diabetes. One drawback of VLCD however is the associated loss of skeletal muscle which affects some patients. Semaglutide is a well-known medication for type 2 diabetes that also improves blood sugar control and facilitates weight loss. Recent research has shown that it may also stimulate muscle growth, meaning it could help to preserve muscle mass during weight loss. Therefore, this research study aims to see whether taking Semaglutide alongside the VLCD reduces the amount of muscle lost, and could improve the long-term outcomes of VLCD. The study will take place in the Medical School building in the Royal Derby Hospital. Up to 45 participants will be recruited and allocated into one of 3 groups: 1. Semaglutide only 2. VLCD only 3. Combined Semaglutide plus VLCD The study is 12 weeks in duration and consists of four visits including two 6-hour visits, one 4-hour visit and one 30-minute visit. The first visit is a short Preliminary Visit where participants are asked to ingest stable isotope drinks for measurement of muscle growth rates and muscle mass. Food intake and physical activity monitoring will also be commenced. Visits 1 \& 3 are identical and occur at the beginning and end of the 12-week intervention period, respectively. During these visits participants will undergo a Dual-energy X-ray absorptiometry (DXA) scan, a right vastus lateralis muscle ultrasound scan \& muscle biopsy, an intravenous glucose tolerance test, electromyography, tests of muscular function, gait \& balance, and questionnaires regarding quality of life \& physical activity. These visits are expected to last up to 6 hours. Visit 2 is a shorter visit mid-way through the 12 weeks, lasting approximately 4.5 hours. Participants will undergo another DXA scan and muscle biopsy in addition to having multiple blood tests taken over a 4-hour period to determine muscle protein breakdown rates. During the 12 weeks, those in the VLCD group will be asked to stick strictly to an 800 kilocalorie very-low calorie diet, whilst those in the Semaglutide group will be required to inject themselves with Semaglutide once a week. Those in the combined group will be asked to do both. All participants will be monitored closely throughout the 12-week period, with regular phone calls and/or emails.

Key Dates

Start date
Sep 15, 2021
Status verified
Oct 2022
Primary completion
Jul 28, 2023
Completion
Jul 28, 2023

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: VLCD only
    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.
  • Active Comparator: Semaglutide only
    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.
  • Experimental: Combined VLCD plus Semaglutide
    Participants in this group will both partake in the VLCD, and take the weekly dose of Semaglutide (as described above).

Primary Outcome Measure

Muscle protein synthesis rate [ Time Frame: 6 weeks ]

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