Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
2 other identifiers
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 obesity
Started Sep 2016
Longer than P75 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedFebruary 8, 2023
February 1, 2023
3 years
September 22, 2016
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Plasma insulin levels
1 month (before and after surgery)
Other Outcomes (17)
Plasma Levels of GLP-1
1 month (before and after surgery)
Plasma Levels of GIP
1 month (before and after surgery)
Plasma Levels of leptin
1 month (before and after surgery)
- +14 more other outcomes
Study Arms (4)
Vertical Sleeve Gastrectomy (VSG) NJ/PO
EXPERIMENTALPatients 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.
Roux-en-Y Gastric Bypass (RYGB) NJ/PO
EXPERIMENTALPatients 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.
Vertical Sleeve Gastrectomy (VSG) PO/PO
EXPERIMENTALPatients 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.
Roux-en-Y Gastric Bypass (RYGB) PO/PO
EXPERIMENTALPatients 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.
Interventions
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
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.
Eligibility Criteria
You may qualify if:
- BMI ≥ 35 kg/m2
- Age 21-65 years
- Weight ≤ 200 kg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- John L. Sawyers Professor of Surgery
Study Record Dates
First Submitted
September 22, 2016
First Posted
November 3, 2016
Study Start
September 1, 2016
Primary Completion
August 21, 2019
Study Completion
January 30, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02