lean mass preservation with resistance exercise and protein during semaglutide/tirzepatide therapy

Conditions: Type 2 Diabetes Mellitus (T2DM)

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 type 2 diabetes initiating semaglutide/tirzepatide therapy. to achieve this aim the study will have the following objectives. in people with type 2 diabetes 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.


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

Keywords: obesity, research