LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy
Recruiting · NCT06885736 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- Dasman Diabetes Institute - Kuwait City, Kuwait