The Effects of Bariatric Surgeries on Glucose Metabolism

Early Phase 1

Recruiting

• Conditions: Hypoglycemia After Gastric Bypass; Post Bariatric Surgery; Gastric Bypass; Sleeve Gastrectomy
• Interventions: Drug: Atropine; Drug: Exendin-(9-39)

• Registration Number: NCT02823665
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Atropine	Atropine	to evaluate the effect of neural activation on insulin secretion and glucose metabolism
Exendin-(9-39)	Exendin-(9-39)	To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

Primary Outcome Measures

Name	Time	Method
Insulin levels measured after nutrient ingestion	Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.

Trial Locations

Locations (2)

Texas Diabetes Institute - University Health System; 🇺🇸 San Antonio, Texas, United States

South Texas Veterans Health Care System; 🇺🇸 San Antonio, Texas, United States