To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery

• Status: Completed
• Trial end date: 2015-11-17
• Target enrollment: 0
• Participant gender: All

Summary

There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part to an intestinal hormone, called GLP-1, that is released into the circulation immediately after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial effects of RYGB surgery on glucose homeostasis in humans.

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

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

• Individuals must be able to consent for their own participation (no mental impairment affecting cognition or willingness to follow study instructions).

• Healthy, weight stable, with previous Roux-en-Y gastric bypass surgery and no clinical evidence of type 2 diabetes either before and after Roux-en-Y gastric bypass surgery.

• Women of childbearing potential must be currently taking/using a method of birth control that is acceptable to the investigators. A pregnancy test will be done at the beginning of each visit. Any woman with a positive pregnancy test will be removed from the study.

• Willingness to return have 8-10ml of blood drawn 25-30 days after the last Xenin infusion; to check for Xenin peptide antibodies that MAY develop. (All efforts will be made to complete this visit during study participation.)

Exclusion Criteria:

• Lacks cognitive ability to sign the consent &/or follow the study directions for themselves.

• Women unwilling to comply with using an acceptable method of contraception during the course of the study, or who are currently breast-feeding.

• Volunteers with a history of Acute Pancreatitis.

• Volunteers with a history of cancer (except for skin cancer).

• Volunteer with a history of Chronic Pancreatitis and/or risk factors for chronic pancreatitis including hypertriglyceridemia (triglycerides >400mg/ml) hypercalcemia (blood calcium level >11.md/dl) and/or the presence of gallstones.

• Subjects taking medications known to affect glucose tolerance.

• Hematocrit from the lab is below 33% (or if the finger stick hemoglobin measured with the HemoCue 201+ is <11.2 g/dl).

• Any major medical conditions, or conditions that in the opinion of the PI make the subject unsuitable for the study.

• Subjects with abnormal kidney function as measured by the Creatinine concentration will be excluded.

• Subjects with a history of active liver disease or AST/ALT levels >2X upper limit of normal will also be excluded.

• Total Bilirubin levels should be <2.

• Subjects unwilling to allow the use of their own blood or albumin in the preparation of the peptides. (The blood will prevent sticking of the peptide to the tubing; an alternative method has been sought but not found.)

• Unwillingness to return have 8-10ml of blood drawn 25-30 days after the last Xenin infusion; to check for Xenin peptide antibodies that MAY develop. (All efforts will be made to complete this visit during study participation.)