Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets
Status:
Recruiting
Trial end date:
2023-07-28
Target enrollment:
Participant gender:
Summary
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.