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This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SG-T: sleeve gastrectomy with tirzepatide | Experimental | In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery. |
|
| SG-A: sleeve gastrectomy alone | Active Comparator | In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mounjaro | Drug | In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide after surgery. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | 18 months after surgery | |
| Type 2 Diabetes | Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement. | 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Administrator | Contact | 312-942-5500 | anna_t_alecci@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Skertich, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
De-identified individual participant data (IPD) that underlie the results will be made available following publication for a period of 3 years, dependent on IRB approval to share the data and execution of a data use agreement. Access will be granted to researchers who submit a methodologically sound proposal approved by their IRB. Requests for data access can be made to the Principal Investigator.
Start: after publication. End: 3 years after publication.
De-identified individual participant data (IPD) that underlie the results will be made available following publication for a period of 3 years, dependent on IRB approval to share the data and execution of a data use agreement. Access will be granted to researchers who submit a methodologically sound proposal approved by their IRB. Requests for data access can be made to the Principal Investigator.
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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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| Sleeve Gastrectomy | Procedure | Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy. |
|
| Type 2 Diabetes | Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement. | 18 months after surgery |
| High Blood Pressure | 12 months after surgery |
| High Blood Pressure | 18 months after surgery |
| High Cholesterol | Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement. | 12 months after surgery |
| High Cholesterol | Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement. | 18 months after surgery |
| Sleep Apnea | Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N). | 12 months after surgery |
| Sleep Apnea | Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N) | 18 months after surgery |
| Complications/Side Effects | 12 months after surgery |
| Complications/Side Effects | 18 months after surgery |
| 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 |