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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| University of New Mexico Cancer Center | OTHER |
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Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD.
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | The drug is being studied to better understand the biological effects of tirzepatide on MASLD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers associated with MASLD | Identification of an changes in biomarkers associated with MASLD with tirzepatide use | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Fat Content | Change in liver fat content with use of tirzepatide | 12 months |
| Liver Stiffness | Change in liver stiffness with use of tirzepatide |
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Inclusion Criteria:
Men and women
Age 18-75
Diagnosis of MASLD based on the following criteria:
BMI >25 kg/m2 OR waist circumference >94 cm (men) or 80cm (women)
Fasting serum glucose >100 mg/dL OR 2-hour post-prandial glucose levels >140mg/dL OR AbA1c >5.7% OR type 2 diabetes OR treatment for type 2 diabetes
Blood pressure >130/85 mmHg OR specific antihypertensive drug treatment
Plasma triglycerides >150mg/dL OR on lipid lowering treatment
Plasma HDL-cholesterol <40mg/dL (men) and <50mg/dL (women) OR on lipid lowering medication
English speaking
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Gonzales, MD | Contact | 15052723840 | KrGonzales@salud.unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eliseo Castillo | UNM Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Health Sciences Center | Recruiting | Albuquerque | New Mexico | 87131 | United States |
IPD will not be shared with other researchers. Data will only be available to study team members.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| 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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| 12 months |
| Body weight | Change in body weight with use of tirzepatide | 12 months |
| Metabolic markers | Changes in lipid profiles, glycemic measures (A1c), inflammatory markers and cytokines, and gut hormones | 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |