Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide

ConditionObesity (BMI>30)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-60

SponsorTechnical University of Munich

About this trial

Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment. However, particularly fast weight loss may be accompanied by a significant loss of muscle mass, which is associated with a reduced metabolic rate at rest and during physical activity, increased insulin resistance, limited mobility, and potential long-term adverse effects. The aim of this clinical trial is to examine the effects of resistance training versus standard of care on contractile thigh muscle volume in patients receiving the dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists 'tirzepatide'.

Eligibility criteria

Qualifiers

Are ≥ 18 years and ≤ 60 years of age

Have a body mass index (BMI) of ≥ 30 kg/m2

Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

In the investigator's opinion, are well motivated, capable, and willing to

Disqualifiers

Have known Type 1 Diabetes, a history of Type 2 Diabetes (including those in remission), a history of ketoacidosis of any aetiology, or a history of hyperosmolar hyperglycaemic state or coma

glycated hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol)

fasting glucose ≥126 mg/dL (≥7.0 mmol/L) Note: If a blood sample is collected under non-fasting conditions and the random glucose value is ≥200 mg/dL (≥11.1 mmol/L), an additional fasting blood sample will be obtained to confirm or exclude diabetes.

Have a self-reported reduction in body weight >5 kg within 3 months prior to screening

Trial design

Treatments tested in this trial

Dual GIP/GLP-1 Receptor Agonist Tirzepatide
Resistance Training

Treatment groups

150 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Technical University of Munich

Lead sponsor

EGYM SE

Collaborator

Source ClinicalTrials.gov