NCT06885736 LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy
| NCT ID | NCT06885736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dasman Diabetes Institute |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2029-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 232 participants in total. It began in 2025-08-07 with a primary completion date of 2029-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age \>/= 18 years * BMI \>/= 27 kg/m2 Exclusion Criteria: * Currently or in the past 6 months participating in any vigorous aerobic activity (\>1h per week) or any resistance exercise. * BP of 160/100mmHg or higher * Any known medical condition that prevents participants from exercising safely * A 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 have undergone or plan to undergo gastric bypass or restrictive bariatric surgery or chronically taking drugs that directly affect GI motility * Any of the following CV conditions in last 2 months: acute MI, stroke or hospitilisation due to CHF * History of NYHA IV CHF * Acute or chronic hepatitits, signs and symptoms of any liver disease other than NAFLD, ALT \> 3 times the upper limit of normal * eGFR \<45mL/min/1.73m2 * Significant uncontrolled endocrine abnormaility in the opinion of clinical investigator * Evidence of active autoimmune abnormality that is likely to requite systemic glucocorticoid treatment in the next 12 months * Had or waiting for an organ transplant * History of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years * Any other aspect of history or condition that may limit the ability of the patient to complete the study * Having been treated with prescription drugs that promote weight loss in the last 3 months * Receiving chronic systemic glucocorticoid therapy within last month
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06885736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06885736 currently recruiting?
Yes, NCT06885736 is actively recruiting participants. Contact the research team at ebaa.alozairi@dasmaninstitute.org for enrollment information.
Where is the NCT06885736 trial being conducted?
This trial is being conducted at Kuwait City, Kuwait.
Who is sponsoring the NCT06885736 clinical trial?
NCT06885736 is sponsored by Dasman Diabetes Institute. The trial plans to enroll 232 participants.
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