Status:
NOT_YET_RECRUITING
LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy
Lead Sponsor:
Dasman Diabetes Institute
Collaborating Sponsors:
University of Glasgow
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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/tirz...
Eligibility Criteria
Inclusion
- Age \>/= 18 years
- BMI 27-45
Exclusion
- 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
- Insulin therapy
- 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 onths
- 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
- Serum calcitonin \>35ng/L
- 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
Key Trial Info
Start Date :
August 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT06885736
Start Date
August 10 2025
End Date
December 31 2029
Last Update
June 26 2025
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