The Effects of Bariatric Surgeries on Glucose Metabolism

Gastric Bypass Clinical Trial

Official title:

The Effects of Bariatric Surgeries on Glucose Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823665
• Other study ID #: 20180070H
• Secondary ID: 1R01DK105379-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 2015
• Est. completion date: August 2026

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Marzieh Salehi, MD MS
• Phone: 210-567-6691
• Email: salehi[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Gastric Bypass
• Hypoglycemia
• Hypoglycemia After Gastric Bypass
• Post Bariatric Surgery
• Sleeve Gastrectomy

Intervention

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.
• Atropine
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.

Locations

Country	Name	City	State
United States	South Texas Veterans Health Care System	San Antonio	Texas
United States	Texas Diabetes Institute - University Health System	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	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
Primary	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.