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The goal of this study is to examine how tirzepatide affects body composition, bone health, and physical performance in older adults over a nine-month period. Participants will take tirzepatide weekly, have clinic visits every 4 weeks, meet study doctor and registered dietitian every 4 weeks in person or video conference, attend group intervention sessions twice a month via video conference, weigh daily with a study-provided smart scale, keep a record of all foods and beverages consumed, and use a study-provided activity tracker to keep track of daily step counts.
This study will enroll 40 older adults with obesity (or overweight with a weight-related comorbidity) in a 9-month pilot to examine the effects of tirzepatide on body composition, bone health, and physical performance. All participants will receive tirzepatide, 5 mg per week and counseling sessions (group and individual) on diet quality and physical activity as well as behavioral strategies to facilitate dietary and physical activity changes. Participants will be expected to weigh themselves daily on a smart scale, record their food and beverage consumption, and keep track of daily step counts over the 9-month intervention period. Body composition, bone health, and physical performance will be measured at baseline prior to intervention and approximately nine months later. This data will be used to examine the effects of tirzepatide on total and appendicular lean and total fat mass measured by DXA; hip and spine bone mineral density measured by DXA; and leg strength and physical performance (expanded Short Physical Performance Battery, 400-m walk).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Tirzepatide injection once weekly for 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Tirzepatide will be initiated at a dose of 2.5 mg weekly and increased as tolerated to 5 mg weekly at four weeks for the remainder of the 9-month intervention period. Participants who are unable to tolerate the 5 mg dose will be decreased to the 2.5 mg dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total body lean mass | Change in total body lean mass will be measured by DXA scan | Baseline to Month 9 |
| Change in appendicular lean mass | Change in appendicular lean mass will be measured by DXA scan | Baseline to Month 9 |
| Change in total body fat mass | Change in total body fat mass will be measured by DXA scan | Baseline to Month 9 |
| Change in total hip bone mineral density | Change in total hip bone mineral density will be measured by DXA scan | Baseline to Month 9 |
| Change in lumbar spine bone mineral density | Change in lumbar spine bone mineral density will be measured by DXA scan | Baseline to Month 9 |
| Change in 400 meter walk time | Change in the time it takes to walk 400 meters (10 laps on an indoor, 20-meter course). The 400 meter walk is a test of exercise tolerance and aerobic fitness. | Baseline to Month 9 |
| Change in lower extremity physical performance score | Change in lower extremity physical performance will be assessed by the expanded Short Physical Performance Battery. Activities include side-by-side, semi-tandem, tandem and one leg stand balance tests; 4 meter walk; 4 meter narrow walk; and time to rise from a chair five times. Total score ranges from 0-4 with higher scores indicating better lower extremity physical performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in thigh intramuscular fat tissue | Change in thigh intramuscular fat tissue will be measured by CT scan | Baseline to Month 9 |
| Change in thigh muscle volume | Change in thigh muscle volume will be measured by CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Houston, PhD | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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|
| Baseline to Month 9 |
| Change in leg strength | Change in leg extensor strength will be assessed using the Keiser AIR300 Leg Press System. | Baseline to Month 9 |
| Baseline to Month 9 |
| Change in total skeletal muscle mass | Change in total skeletal muscle mass will be assessed by D3 creatine | Baseline to Month 9 |
| Change in total volumetric bone mineral density of the hip | Change in total volumetric bone mineral density of the hip will be measured by CT scan | Baseline to Month 9 |
| Change in hip bone strength | Change in hip bone strength will be measured by CT scan | Baseline to Month 9 |
| Change in total volumetric bone mineral density of the radius | Change in total volumetric bone mineral density of the radius will be measured by high-resolution peripheral quantitative CT | Baseline to Month 9 |
| Change in total volumetric bone mineral density of the tibia | Change in total volumetric bone mineral density of the tibia will be measured by high-resolution peripheral quantitative CT | Baseline to Month 9 |
| Change in c-telopeptide of type 1 collagen (CTX) | Change in c-telopeptide of type 1 collagen (CTX) will be measured by enzyme-linked immunosorbent assay | Baseline to Month 9 |
| Change in procollagen type 1 n-terminal propeptide (P1NP) | Change in procollagen type 1 n-terminal propeptide (P1NP) will be measured by enzyme-linked immunosorbent assay | Baseline to Month 9 |
| Change in bone-specific alkaline phosphatase (BALP) | Change in bone-specific alkaline phosphatase (BALP) will be measured by enzyme-linked immunosorbent assay | Baseline to Month 9 |
| Change in osteocalcin | Change in osteocalcin will be measured by enzyme-linked immunosorbent assay | Baseline to Month 9 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |