RECRUITING

Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls.

Official Title

Hormonal and Neural Control of Insulin Secretion Following Gastric Bypass Surgery

Quick Facts

Study Start:2009-10
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00992901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hypoglycemic RYGB patients with documented blood glucose level \<50 mg/dl
  2. * Asymptomatic individuals with bariatric surgery
  3. * Healthy non-surgical patients with no personal history of diabetes
  4. * Subjects must physically be able to come to our clinical research center at Cedars-Sinai Medical Center
  1. * 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 melitis; development of any serious medical or psychiatric illness during recruitment or studies;
  2. * RYGB patients will also be disqualified if they have gastric outlet obstruction or severe diarrhea
  3. * Healthy non-surgical patients with personal history of diabetes
  4. * History of glaucoma
  5. * Uncontrolled hypertension (any subjects with BP\>140/90 and history of dyslipidemia
  6. * Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
  7. * Myasthenia gravis
  8. * Brain pathology
  9. * Enlarged prostate in men

Contacts and Locations

Study Contact

Marzieh Salehi, MD MS
CONTACT
210-567-6691
salehi@uthscsa.edu
Andrea Hansis-Diarte
CONTACT
210-567-6691
hansisdiarte@uthscsa.edu

Principal Investigator

Marzieh Salehi, MD, MS
PRINCIPAL_INVESTIGATOR
Marzieh Salehi

Study Locations (Sites)

Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Marzieh Salehi, MD, MS, PRINCIPAL_INVESTIGATOR, Marzieh Salehi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2009-10
Study Completion Date2026-08

Study Record Updates

Study Start Date2009-10
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • gastric bypass surgery
  • glucose tolerance
  • Insulin response to meal ingestion
  • Gut hormone and neural response to meal ingestion

Additional Relevant MeSH Terms

  • Post Bariatricsurgery
  • Hypoglycemia