Overview

This trial is active, not recruiting.

Conditions post bariatric surgery, gastric bypass, sleeve gastrectomy, hypoglycemia after gastric bypass
Treatments exendin-(9-39), atropine
Phase phase 0
Sponsor Cedars-Sinai Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date July 2015
End date July 2020
Trial size 200 participants
Trial identifier NCT02823665, 1R01DK105379-01, 42886

Summary

The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Arm
(Experimental)
To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
exendin-(9-39) no other name for Exendin-(9-39)
A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
(Experimental)
to evaluate the effect of neural activation on insulin secretion and glucose metabolism
atropine Atropine sulfate
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.

Primary Outcomes

Measure
Insulin levels measured after nutrient ingestion
time frame: Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl - Asymptomatic individuals with bariatric surgery - Healthy non-surgical patients with no personal history of diabetes - Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center Exclusion Criteria: - Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies; - RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea. - Healthy non-surgical patients with personal history of diabetes For administration of atropine, the following exclusions also apply: - History of glaucoma - Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia - Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study) - Myasthenia gravis - Brain pathology - Enlarged prostate in men

Additional Information

Official title The Effects of Bariatric Surgeries on Glucose Metabolism
Principal investigator Marzieh Salehi, MD, MS
Description The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures. Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Cedars-Sinai Medical Center.