Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
NCT ID: NCT02953587
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2016-09-30
2023-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Vertical Sleeve Gastrectomy (VSG) NJ/PO
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.
Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Saline
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.
Roux-en-Y Gastric Bypass (RYGB) NJ/PO
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.
Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Saline
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.
Vertical Sleeve Gastrectomy (VSG) PO/PO
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.
Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Saline
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.
Roux-en-Y Gastric Bypass (RYGB) PO/PO
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.
Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Saline
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.
Interventions
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Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Saline
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 21-65 years
* Weight ≤ 200 kg
Exclusion Criteria
* Medications that alter insulin sensitivity or carbohydrate metabolism
* Positive pregnancy test
* Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. Chronic Ulcerative Colitis, Crohn's disease, celiac sprue)
* Prior gastric or intestinal surgery or pancreas resection
* History of cardiovascular disease, including but not limited to: myocardial infarction, angioplasty, arrhythmia, uncontrolled hypertension
* History of chronic kidney disease or renal insufficiency; creatinine \> 1.8 mg/dl.
* History of chronic liver disease, including but not limited to: cirrhosis, hepatitis, portal hypertension; AST and/or ALT \> 2x the upper limit of normal.
* Abnormal ECG
21 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Naji Abumrad
John L. Sawyers Professor of Surgery
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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111237-Protocol II
Identifier Type: -
Identifier Source: org_study_id
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