beta
Trial Radar AI
One study matched filter criteria
Card View
Back to Search

The Effects of Bariatric Surgeries on Glucose Metabolism Early Phase 1 200

Recruiting
Clinical Trial NCT02823665 is designed to study Other for Post Bariatric Surgery, Gastric Bypass, Sleeve Gastrectomy, Hypoglycemia After Gastric Bypass. It is a Early Phase 1 interventional study that is recruiting, having started on July 1, 2015, with plans to enroll 200 participants. Led by The University of Texas Health Science Center at San Antonio, it is expected to complete by August 1, 2027. The latest data from ClinicalTrials.gov was last updated on September 9, 2025.
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...

Show More
Official Title

The Effects of Bariatric Surgeries on Glucose Metabolism

Conditions
Post Bariatric SurgeryGastric BypassSleeve GastrectomyHypoglycemia After Gastric Bypass
Other Study IDs
NCT ID Number
NCT02823665
Start Date (Actual)
2015-07
Last Update Posted
2025-09-09
Completion Date (Estimated)
2027-08
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
gastric bypass surgery
Hypoglycemia
sleeve gastrectomy
glucose tolerance
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExendin-(9-39)
To evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
Exendin-(9-39)
A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
ExperimentalAtropine
to evaluate the effect of neural activation on insulin secretion and glucose metabolism
Atropine
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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
The University of Texas Health Science Center at San Antonio logoThe University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) logoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Central Contact
Contact: Marzieh Salehi, MD MS, 210-567-6691, [email protected]
Contact: Jennifer Foster, MSN, 210-450-8696, [email protected]
2 Study Locations in 1 Countries

Texas

Texas Diabetes Institute - University Health System, San Antonio, Texas, 78207, United States
Marzieh Salehi, MD, Contact, 210-567-6691, [email protected]
Jennifer Foster, MSN, Contact, 210-450-8696, [email protected]
Marzieh Salehi, MD, Principal Investigator
Recruiting
South Texas Veterans Health Care System, San Antonio, Texas, 78229, United States
Marzieh Salehi, MD, Contact, 210-567-6691, [email protected]
Jennifer Foster, MSN, Contact, 210-450-8696, [email protected]
Marzieh Salehi, MD, Principal Investigator
Recruiting