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

What Was Tested

This registered phase 4 trial tested Semaglutide.

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.

It had three arms (groups): VLCD only (active comparator), Semaglutide only (active comparator) and Combined VLCD plus Semaglutide (experimental).

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.

The registry classes the interventions as dietary supplement and drug.

Who Took Part

The registry lists 45 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: BMI \> 50kg·m-2; current pregnancy or breastfeeding, or intention to fall pregnant within the next 3 months; uncontrolled hypertension (blood pressure \>200/120mmhg).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-09-15 with completion listed for 2023-07-28.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Muscle protein synthesis rate (time frame: 6 weeks). Muscle protein breakdown rate (time frame: 6 weeks).

It also tracked 11 secondary outcomes, for example Skeletal muscle mass, Fat mass, Total body weight, Whole body insulin sensitivity, Pancreatic beta cell function and Skeletal muscle strength.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 45 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.