Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06885736

LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy

Led by Dasman Diabetes Institute · Updated on 2026-04-21

232

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

Sponsors

D

Dasman Diabetes Institute

Lead Sponsor

U

University of Glasgow

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of the current study is to determine whether resistance exercise and/or protein intake can preserve lean mass and improve physical function in patients with obesity initiating semaglutide/tirzepatide therapy. To achieve this aim the study will have the following objectives. In people with obesity initiating semaglutide/tirzepatide therapy 1. Form a PPI group to refine the study protocol and establish study materials, 2. Quantify the effects of a pragmatic resistance exercise intervention and/or increasing protein intake on lean mass and physical function during semaglutide/tirzepatide induced weight loss, 3. Establish whether the resistance exercise intervention and/or increasing protein intake has concomitant benefits on glycaemic control, lipids, liver function, quality of life, physical activity and sleep during semaglutide/tirzepatide induced weight loss. The participants will: Begin their weight loss medication, starting at a low dose and then increasing the dose to maximize weight loss. They will be randomly assigned by a computer to ONE of the following groups and will be followed up to 6-months: * Control group * Protein intake group * Muscle strengthening exercise group * Muscle strengthening exercise AND protein intake group.

CONDITIONS

Official Title

LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3;= 18 years
  • BMI �3;= 27 kg/m2
Not Eligible

You will not qualify if you...

  • Currently or in the past 6 months participating in any vigorous aerobic activity (>1h per week) or any resistance exercise
  • Blood pressure of 160/100 mmHg or higher
  • Any known medical condition that prevents participants from exercising safely
  • Personal or family history of medullary thyroid carcinoma
  • Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • History of chronic or acute pancreatitis
  • History of proliferative diabetic retinopathy or diabetic maculopathy
  • History of ketoacidosis or hyperosmolar state/coma
  • History of severe hypoglycaemia and/or hypoglycaemia unawareness within last 6 months
  • Clinically significant gastric emptying abnormality or having undergone or planning to undergo gastric bypass or restrictive bariatric surgery or chronically taking drugs that affect GI motility
  • Cardiovascular conditions in the last 2 months such as acute myocardial infarction, stroke, or hospitalization due to congestive heart failure
  • History of NYHA IV congestive heart failure
  • Acute or chronic hepatitis, liver disease signs/symptoms other than NAFLD, ALT > 3 times upper limit of normal
  • eGFR <45 mL/min/1.73m2
  • Significant uncontrolled endocrine abnormality
  • Evidence of active autoimmune abnormality likely requiring systemic glucocorticoid treatment in next 12 months
  • Had or waiting for an organ transplant
  • History of active or untreated malignancy or remission from clinically significant malignancy for less than 5 years
  • Any condition limiting ability to complete the study
  • Treatment with prescription weight loss drugs in the last 3 months
  • Receiving chronic systemic glucocorticoid therapy within last month

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dasman Diabetes Institute

Kuwait City, Kuwait

Actively Recruiting

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Research Team

D

Dr Ebaa Al Ozairi

CONTACT

P

Prof Stuart Gray

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy | DecenTrialz