Clinical trial NCT02953587: Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
Official title: Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Bariatric Surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-11-03
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in plasma glucose levels with ghrelin versus saline.
timeFrame: 1 month (before and after surgery)
Secondary outcomes:
measure: Plasma insulin levels
timeFrame: 1 month (before and after surgery)
Other outcomes:
measure: Plasma Levels of GLP-1
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of GIP
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of leptin
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of pancreatic polypeptide
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Peptide YY (PYY)
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of C-Peptide
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of glucagon
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Cholecystokinin (CCK)
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Cholecystokinin Adrenocorticotropic Hormone (ACTH)
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Human Growth Hormone (HGH)
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Cortisol
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of insulin-like growth factor 1 (IGF-1)
timeFrame: 1 month (before and after surgery)
measure: Acyl and desacyl ghrelin
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Bile Acids
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Free Fatty Acids (FFAs)
timeFrame: 1 month (before and after surgery)
measure: Plasma Levels of Triglycerides (TG)
timeFrame: 1 month (before and after surgery)
measure: Performance on Visual Analog Scale for Hunger
timeFrame: 1 month (before and after surgery)
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: