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Recruiting Not applicable NCT06885736

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

No applicable phase (e.g. observational)
Conditions: Obesity

Sponsor: Dasman Diabetes Institute

trial.available_in: БГ
Overview
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 participate
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
Interventions
Resistance exercise
BEHAVIORAL
Protein Intake
DIETARY_SUPPLEMENT
Locations 1
Kuwait (1)
Dasman Diabetes Institute
Kuwait City
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.08.2025
Completion date
31.12.2029
Registry ID
NCT06885736
Source
clinicaltrials.gov
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