Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

Obesity Clinical Trial

Official title:

Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953587
• Other study ID #: 111237-Protocol II
• Secondary ID: R01DK091748
• Status: Completed
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 30, 2023
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.

Drug:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Levels of GLP-1	Metabolic panel to include plasma levels of GLP-1	1 month (before and after surgery)
Other	Plasma Levels of GIP	Metabolic panel to include plasma levels of GIP	1 month (before and after surgery)
Other	Plasma Levels of leptin	Metabolic panel to include plasma levels of leptin	1 month (before and after surgery)
Other	Plasma Levels of pancreatic polypeptide	Metabolic panel to include plasma levels of pancreatic polypeptide	1 month (before and after surgery)
Other	Plasma Levels of Peptide YY (PYY)	Metabolic panel to include plasma levels of PYY	1 month (before and after surgery)
Other	Plasma Levels of C-Peptide	Metabolic panel to include plasma levels of C-Peptide	1 month (before and after surgery)
Other	Plasma Levels of glucagon	Metabolic panel to include plasma levels of glucagon	1 month (before and after surgery)
Other	Plasma Levels of Cholecystokinin (CCK)		1 month (before and after surgery)
Other	Plasma Levels of Cholecystokinin Adrenocorticotropic Hormone (ACTH)		1 month (before and after surgery)
Other	Plasma Levels of Human Growth Hormone (HGH)		1 month (before and after surgery)
Other	Plasma Levels of Cortisol		1 month (before and after surgery)
Other	Plasma Levels of insulin-like growth factor 1 (IGF-1)		1 month (before and after surgery)
Other	Acyl and desacyl ghrelin		1 month (before and after surgery)
Other	Plasma Levels of Bile Acids		1 month (before and after surgery)
Other	Plasma Levels of Free Fatty Acids (FFAs)		1 month (before and after surgery)
Other	Plasma Levels of Triglycerides (TG)		1 month (before and after surgery)
Other	Performance on Visual Analog Scale for Hunger		1 month (before and after surgery)
Primary	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	Plasma insulin levels		1 month (before and after surgery)