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

Launched by DASMAN DIABETES INSTITUTE · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how resistance exercise and protein intake can help people with type 2 diabetes maintain their muscle mass and improve their physical abilities while taking medications called semaglutide or tirzepatide, which are used for weight loss. The study will involve participants who are starting these medications and will focus on whether adding exercise or protein can enhance their overall health, including blood sugar control and quality of life.

To participate, individuals must be at least 18 years old, have a confirmed diagnosis of type 2 diabetes, and have a body mass index (BMI) between 25 and 45. Those interested will be randomly assigned to one of four groups: a control group, a group focused on increasing protein intake, a group that will do muscle-strengthening exercises, or a group that will do both exercises and increase protein intake. The study will follow participants for up to six months, during which they will be monitored to see how these interventions impact their health as they lose weight. It's important to note that certain health conditions and recent treatments may exclude someone from participating, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Physician confirmed type 2 diabetes.
• • Age \>/= 18 years
• • BMI 25-45
• 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
• • 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