Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

Vanderbilt University Medical Center

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Procedure: Oral Glucose Tolerance Test (OGTT); Drug: Saline; Drug: Human Ghrelin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02953587

111237-Protocol II

R01DK091748 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 4 patient groups

Vertical Sleeve Gastrectomy (VSG) NJ/PO

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Human Ghrelin

Procedure: Oral Glucose Tolerance Test (OGTT)

Roux-en-Y Gastric Bypass (RYGB) NJ/PO

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Human Ghrelin

Procedure: Oral Glucose Tolerance Test (OGTT)

Vertical Sleeve Gastrectomy (VSG) PO/PO

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Human Ghrelin

Procedure: Oral Glucose Tolerance Test (OGTT)

Roux-en-Y Gastric Bypass (RYGB) PO/PO

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Human Ghrelin

Procedure: Oral Glucose Tolerance Test (OGTT)