Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.
The major objectives are:
Participants will:
Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months.
Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug.
Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care plus Drug | Experimental | Participant receives drug for 3 months prior to surgery |
|
| Standard of Care Alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tirzepatide | Drug | Participants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory markers c reactive protein (CRP) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | Baseline and 3 months post-drug |
| Change in inflammatory markers interleukin 6 (IL-6) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | Baseline and 3 months post-drug |
| Change in inflammatory markers tumor necrosis factor (TNF) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | Baseline and 3 months post-drug |
| change in inflammatory markers (leptin) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | Baseline and 3 months post-drug |
| change in inflammatory markers (adiponectin) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | Baseline and 3 months post-drug |
| change in inflammatory markers renin-angiotensin-aldosterone system (RAAS) | Inflammatory markers will be measured by ELISA in blood samples drawn from patient. | Baseline and 3 months post-drug |
| RNA sequencing | Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | patient weight will be measured | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| 30-day surgical complications | Surgical complications will be assessed as standard of care and data evaluated for this study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlene Starr, PhD | Contact | 859-323-0471 | marlene.starr@uky.edu | |
| Varun Jain, MD | Contact | vja233@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marlene Starr, PhD | University of Kentucky | Principal Investigator |
| Varun Jain, MD | University of Kentucky | Study Director |
| William B Inabnet, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41643256 | Derived | Jain V, McMullen CA, Kimbrough JI, Rockich AK, Davenport DL, Hawk GS, Nikolajczyk BS, Kern PA, Fisher SJ, Steiner JP, Inabnet WB 3rd, Starr ME. Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients With Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial. J Surg Res. 2026 Mar;319:58-65. doi: 10.1016/j.jss.2026.01.004. Epub 2026 Feb 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Standard of Care | Behavioral | Participants will be educated on dietary and lifestyle changes |
|
| at time of surgery |
| 1-,6-, and 12-months post surgery |
| change in inflammatory markers c reactive protein (CRP) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | 1-, 6-, and 12-months post surgery |
| change in inflammatory markers interleukin 6 (IL-6) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | 1-, 6-, and 12-months post surgery |
| change in inflammatory markers tumor necrosis factor (TNF) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | 1-, 6-, and 12-months post surgery |
| change in inflammatory markers (leptin) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | 1-, 6-, and 12-months post surgery |
| change in inflammatory markers (adiponectin) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | 1-, 6-, and 12-months post surgery |
| change in inflammatory markers renin-angiotensin-aldosterone system (RAAS) | Inflammatory marker will be measured by ELISA in blood samples drawn from patient. | 1-, 6-, and 12-months post surgery |
| change in blood pressure | blood pressure per standard method in clinic | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| Change in Hemoglobin A1c | HbA1c will be measured by clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| change in blood glucose | blood glucose will me measured in clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| change in cholesterol | cholesterol measured in clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| change in high-density lipoprotein (HDL) | high-density lipoprotein (HDL) measured in clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| change in low-density lipoprotein (LDL) | low-density lipoprotein measured by clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| change in triglycerides | triglycerides measured in clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| change in insulin | insulin measured in clinic lab | Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery |
| University of Kentucky |
| Study Director |
| Simon J Fisher, MD. PhD | University of Kentucky | Study Director |
| Philip A Kern, MD | University of Kentucky | Study Director |
| Barbara Nikolajczyk, PhD | University of Kentucky | Study Director |
| 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 |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |