GLP-1R Actions on Muscle and the Skeleton
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPennington Biomedical Research Center
About this trial
The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects will have a BMI between 30kg/m2
40kg/m2 (inclusive)
Be between 18 and 50 years of age (inclusive).
Non-Hispanic Black males and females will be enrolled at PBRC.
Disqualifiers
Menopausal females.
Subjects on systemic corticosteroids or other agents known to increase loss of muscle and bone mass.
Subjects who are on medications that increase or decrease weight status.
Subjects having contraindications to tirzepatide in the package insert.
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugGLP-1 based treatment for obesity
Lifestyle toolkit
Behavioral2 ABBOTT protein shakes daily and resistance-based exercise x 3 days per week.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Treatment/intervention groupExperimental treatment 1 intervention
Group B: Control/PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in fat free mass (FFM) using DXA imaging. FFM equals all body composition that is not fat mass. This includes bone, skeletal muscle, organs, water and all connective tissues. The unit of measurement is in kilograms (kg) at baseline, 3 and 6 mo.
DXA (Dual energy Xray absorptiometry)
Time frame
Baseline and time 3, and 6 months.Secondary outcomes
1
MRI (thigh) without contrast
To assess for muscle quality (% of skeletal muscle to intermuscular fat)
Time frame
Month 1 (baseline), month 3, month 6 (final visit)2
Osteocalcin
Blood draw, metabolism biomarker
Time frame
Month 1 (baseline), month 3, month 6 (final visit)3
Irisin
Blood draw, bone health biomarker
Time frame
Month 1 (baseline), month 3, month 6 (final visit)4
Procollagen 1 N-terminal peptide (P1NP)
Blood draw, bone health biomarker
Time frame
Month 1 (baseline), month 3, and month 6 (final visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pennington Biomedical Research Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov