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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK091748 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertical Sleeve Gastrectomy (VSG) NJ/PO | Experimental | Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively. |
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| Roux-en-Y Gastric Bypass (RYGB) NJ/PO | Experimental | Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively. |
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| Vertical Sleeve Gastrectomy (VSG) PO/PO | Experimental | Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose Tolerance Test (OGTT) | Procedure | Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma glucose levels with ghrelin versus saline. | The objective for this protocol is to determine if ghrelin infusion worsens glucose tolerance during jejunal administration of glucose and if the response is difference after bariatric surgery (RYGB or VSG). | 1 month (before and after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma insulin levels | 1 month (before and after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels of GLP-1 | Metabolic panel to include plasma levels of GLP-1 | 1 month (before and after surgery) |
| Plasma Levels of GIP | Metabolic panel to include plasma levels of GIP |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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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 |
|---|---|
| D005951 | Glucose Tolerance Test |
| D054439 | Ghrelin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Roux-en-Y Gastric Bypass (RYGB) PO/PO | Experimental | Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed. |
|
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| Human Ghrelin | Drug | Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT. |
|
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| Saline | Drug | Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions. |
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| 1 month (before and after surgery) |
| Plasma Levels of leptin | Metabolic panel to include plasma levels of leptin | 1 month (before and after surgery) |
| Plasma Levels of pancreatic polypeptide | Metabolic panel to include plasma levels of pancreatic polypeptide | 1 month (before and after surgery) |
| Plasma Levels of Peptide YY (PYY) | Metabolic panel to include plasma levels of PYY | 1 month (before and after surgery) |
| Plasma Levels of C-Peptide | Metabolic panel to include plasma levels of C-Peptide | 1 month (before and after surgery) |
| Plasma Levels of glucagon | Metabolic panel to include plasma levels of glucagon | 1 month (before and after surgery) |
| Plasma Levels of Cholecystokinin (CCK) | 1 month (before and after surgery) |
| Plasma Levels of Cholecystokinin Adrenocorticotropic Hormone (ACTH) | 1 month (before and after surgery) |
| Plasma Levels of Human Growth Hormone (HGH) | 1 month (before and after surgery) |
| Plasma Levels of Cortisol | 1 month (before and after surgery) |
| Plasma Levels of insulin-like growth factor 1 (IGF-1) | 1 month (before and after surgery) |
| Acyl and desacyl ghrelin | 1 month (before and after surgery) |
| Plasma Levels of Bile Acids | 1 month (before and after surgery) |
| Plasma Levels of Free Fatty Acids (FFAs) | 1 month (before and after surgery) |
| Plasma Levels of Triglycerides (TG) | 1 month (before and after surgery) |
| Performance on Visual Analog Scale for Hunger | 1 month (before and after surgery) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |