Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT00992901

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

Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-09-09

160

Participants Needed

2

Research Sites

930 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 with gastric outlet obstruction or severe diarrhea
  • Healthy non-surgical patients with personal history of diabetes
  • History of glaucoma (for atropine administration)
  • Uncontrolled hypertension (BP >140/90) and history of dyslipidemia (for atropine administration)
  • Taking medication that might interact with atropine and cannot be stopped (for atropine administration)
  • Myasthenia gravis (for atropine administration)
  • Brain pathology (for atropine administration)
  • Enlarged prostate in men (for atropine administration)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Texas Diabetes Institute - University Health System

San Antonio, Texas, United States, 78207

Actively Recruiting

2

South Texas Veterans Health Care System

San Antonio, Texas, United States, 78229

Actively Recruiting

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Research Team

M

Marzieh Salehi, MD MS

CONTACT

J

Jennifer Foster, MSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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