Keeping lean muscle during semaglutide or tirzepatide with resistance exercise and extra protein

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with obesity who are starting semaglutide or tirzepatide will be enrolled and asked to follow a pragmatic resistance exercise program and/or increase their protein intake while their medication dose is titrated. A patient and public involvement (PPI) group will help refine the protocol and study materials. The study will measure changes in lean mass and physical function and will also track effects on blood sugar, lipids, liver tests, quality of life, activity and sleep. Interventions are behavioral (exercise and dietary protein) delivered alongside standard medication care.

Why it matters

Who can join: the full rules

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

Where it's running

• Dasman Diabetes Institute
  Kuwait City, Kuwait Recruiting

Study contacts

• Study coordinator: Dr Ebaa Al Ozairi
• Email: ebaa.alozairi@dasmaninstitute.org
• Phone: +965 22242999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.