← Trials/Trial dossier/NCT07156331

REBUILD

Not yet recruiting

Research on Effects of Drugs on Body Composition and Function With Imaging in Diabetes

Lead sponsor

Kristin Clemens

Assets

Semaglutide / Tirzepatide

Listed sites

0

Recruiting sites

Enrollment

20

estimated

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Skeletal muscle mass at 1-yearTimed Up-and-Go (TUG) at 1-yearGait Speed at 1-year

Identifiers

Registered as

NCT IDNCT07156331
Org study IDREBUILD

Timeline

Milestones

Study first posted2025-09-05actual
Last update posted2025-09-05actual
Study start2025-10-01estimated
Primary completion2027-10-01estimated
Study completion2027-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adults aged 18 or older with type 2 diabetes that have recently been started on semaglutide or tirzepatide under the care of a physician.

Inclusion criteria

Be at least 18 years old
Have type 2 diabetes
Have recently been started on semaglutide or tirzapatide under the care of a physician
Be able to speak and read English

Exclusion criteria

Are pregnant or breastfeeding
Are unable to perform functional tests
Are unable to provide informed consent
Have any contraindication to PET/CT scan
Had a change in body weight over 5 kilograms within 90 days before starting a GLP-1RA or GLP-1RA/GIP
Had previous or planned (during the study period) bariatric surgery in the subsequent 12 months.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
6
Weight & body composition
3
Glycemic / diabetes
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Change in skeletal muscle mass at 1-year

Time frame:Change from baseline to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in skeletal muscle quality at 3 and 6 months

Time frame:Change from baseline to 3 months, change from baseline to 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in skeletal muscle quality at 3 and 6 months

Time frame:Change from baseline to 3 months, change from baseline to 6 months

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Other/protocol endpoint/low confidence

Glucose Metabolism in Muscle, Bone and Kidney

Time frame:12 months

change from baseline, improvement

Other clinical outcomes

6 endpoints
Primary/protocol endpoint

Change in Timed Up-and-Go (TUG) at 1-year

Time frame:Change from baseline to 12 months

change from baseline, improvement

Primary/protocol endpoint

Change in Gait Speed at 1-year

Time frame:Change from baseline to 12 months

change from baseline, improvement

Primary/protocol endpoint

Change in Handgrip Strength at 1-year

Time frame:Change from baseline to 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Timed Up-and-Go (TUG) at 3 and 6 months

Time frame:Change from baseline to 3 months, change from baseline to 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Gait Speed at 3 and 6 months

Time frame:Change from baseline to 3 months, change from baseline to 6 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Handgrip Strength at 3 and 6 months

Time frame:Change from baseline to 3 months, change from baseline to 6 months

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Blood Flow in Muscle, Bone and Kidney

Time frame:12 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.