← Human Trials & Peer-Reviewed Studies

Lifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide

Plain-language guide to NCT06497595: not phased randomized trial of Semaglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06497595
Phase
not phased
Status
recruiting participants
Start
2025-05-11
Completion (planned or actual)
2027-09-30
Participants
60 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Type 2 Diabetes Mellitus in Obese
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Semaglutide.

This study aims to test whether a multi-disciplinary intervention involving exercise and nutrition can slow down the decline in physical function, muscle strength and mass in older adults (aged 65 and above) with Type 2 diabetes (T2D) and obesity treated with Semaglutide.

The main questions it aims to answer are: In older people with T2D and obesity, treated with Semaglutide, does a multi-disciplinary intervention of exercise and nutrition compared to standard health recommendations: 1.

It had two arms (groups): multi-disciplinary intervention group (MDIG) (experimental) and general health recommendations control group (GHRG) (active comparator).

The registry classes the interventions as behavioral and other.

More on the Plan

Participants aged 65 years and older, with both type 2 diabetes (T2D) and overweight / obesity, will be randomly allocated to either a (1) Semaglutide and multi-disciplinary intervention group (MDIG) comprised of exercise and diet or (2) Semaglutide and general health recommendations control group (CG).

Participants in the MDIG will undergo a once-weekly group exercise training that will be delivered online, followed by 2 unsupervised home-based sessions.

Weekly phone calls will be used in order to measure adherence to the exercise program.

In addition, personal nutritional counseling will be administered by a certified dietitian every 2 weeks for the first 4 weeks and every 4 weeks for the remaining 22 weeks via a virtual meeting platform (i.e., "ZOOM").

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: Patients 65 years and above. Patients who were previously diagnosed with type 2 diabetes. Overweight / obesity (body mass index, BMI ≥ 27 kg/m2).

The full record lists 3 inclusion and 19 exclusion criteria; among the exclusions: patients who are in active nutritional therapy; patients who reported a weight loss of \>5kg within 90 days of screening; patients who were on glucagon-like peptide-1 receptor agonists (glp-1-ra) treatment during the last 3 months.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-05-11 with completion listed for 2027-09-30.

It ran at 2 sites in Israel (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Thigh muscle volume (TMV) (time frame: 26 weeks).

It also tracked 12 secondary outcomes, for example Thigh muscle volume (TMV), Sit to stand test (STS) score, Hand grip strength test score, Timed up and go (TUG) test score, 6-minute walk test (6MWT) score and 10-meter walk test (10MWT) score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.