Recruiting
Early Phase 1

Bariatric Surgery

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT02823665

Conditions

Post Bariatric Surgery

Gastric Bypass

Sleeve Gastrectomy

Hypoglycemia After Gastric Bypass

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Exendin-(9-39)

Atropine

Study Details

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.

Conditions

Post Bariatric Surgery

Gastric Bypass

Sleeve Gastrectomy

Hypoglycemia After Gastric Bypass

Study ID

NCT02823665

Start date

Jul, 2015

Status verified date

Sep, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Exendin-(9-39)

To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

experimental: Atropine

to evaluate the effect of neural activation on insulin secretion and glucose metabolism

Interventions

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.

Primary outcome 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. ]

Central Contacts and Locations

Central contacts

Marzieh Salehi, MD MS

210-567-6691salehi@uthscsa.edu

Jennifer Foster, MSN

210-450-8696fosterj6@uthscsa.edu

Locations

Texas Diabetes Institute - University Health System

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Marzieh Salehi, MD

210-567-6691hansisdiarte@uthscsa.edu

Jennifer Foster, MSN

210-450-8696fosterj6@uthscsa.edu

Principal Investigator:

Marzieh Salehi, MD

South Texas Veterans Health Care System

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Marzieh Salehi, MD

210-567-6691salehi@uthscsa.edu

Jennifer Foster, MSN

210-450-8696fosterj6@uthscsa.edu

Principal Investigator:

Marzieh Salehi, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • gastric bypass surgery
  • Hypoglycemia
  • sleeve gastrectomy
  • glucose tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.