DRUG
Exendin-(9-39)
A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
Status
Recruiting
Phase
Early Phase 1
Enrollment
200
Locations
2
Results
Not posted
Publications
0
Study 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.
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.
Interventions
DRUG
A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
DRUG
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
Timeline
First posted
Jul 6, 2016
Study start
Jul 2015
Primary completion
Aug 2026
Study completion
Aug 2027
Results posted
Not reported
Registry updated
Sep 9, 2025
Outcomes
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.
Not reported in the indexed record.
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Texas Diabetes Institute - University Health System
San Antonio, Texas, United States
South Texas Veterans Health Care System
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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