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RecruitingAccepts healthy volunteersEarly Phase 1

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

The University of Texas Health Science Center at San Antonio · NCT00992901

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
160
US sites recruiting
2
Study start
October 2009
Record last updated
September 9, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Exendin-(9-39); Atropine; GLP-1 and GIP

Conditions: Post Bariatricsurgery; Hypoglycemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 at 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 melitis; development of any serious medical or psychiatric illness during recruitment or studies;
  • RYGB patients will also 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

Recruiting US locations

  • Texas Diabetes Institute - University Health System

    San Antonio, TX 78207

    Site contact: Jennifer Foster, MSN · 210-450-8696 · fosterj6@uthscsa.edu

  • South Texas Veterans Health Care System

    San Antonio, TX 78229

    Site contact: Marzieh Salehi · 210-567-6691 · salehi@uthscsa.edu

Study contacts (from the official record)

  • Marzieh Salehi, MD MS · 210-567-6691 · salehi@uthscsa.edu
  • Jennifer Foster, MSN · 210-450-8696 · fosterj6@uthscsa.edu
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Role of Neural and Hormonal Regulation Factors on Insulin… (NCT00992901) | Bored Studies