Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

• Status: Active, not recruiting
• Trial end date: 2022-10-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

• BMI ≥ 35 kg/m2

• Age 21-65 years

• Weight ≤ 200 kg

Exclusion Criteria:

• Type 2 or Type 1 diabetes

• 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