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Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery Early Phase 1 160

Recruiting
Clinical Trial NCT00992901 is designed to study Other for Post Bariatricsurgery, Hypoglycemia. It is a Early Phase 1 interventional study that is recruiting, having started on October 1, 2009, with plans to enroll 160 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
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 ...Show More
Detailed 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 ...Show More
Official Title

Hormonal and Neural Control of Insulin Secretion Following Gastric Bypass Surgery

Conditions
Post BariatricsurgeryHypoglycemia
Other Study IDs
  • 18-070H
  • DK083554 (Other Grant/Funding Number) (NIDDK)
NCT ID Number
NCT00992901
Start Date (Actual)
2009-10
Last Update Posted
2025-09-09
Completion Date (Estimated)
2027-08
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
gastric bypass surgery
glucose tolerance
Insulin response to meal ingestion
Gut hormone and neural response to meal ingestion
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExendin-(9-39)
To evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
Exendin-(9-39)
A physiological study to evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
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
ExperimentalGLP-1 and GIP
to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
GLP-1 and GIP
A physiological study to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Gut hormones and neural signaling contribution to insulin secretion rate and glucose tolerance
Each study of 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 at 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 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
The University of Texas Health Science Center at San Antonio logoThe University of Texas Health Science Center at San Antonio
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
Jennifer Foster, MSN, Contact, 210-450-8696, [email protected]
Marzieh Salehi, MD, MS, Contact, 210-567-6691, [email protected]
Marzieh Salehi, Principal Investigator
Recruiting
South Texas Veterans Health Care System, San Antonio, Texas, 78229, United States
Marzieh Salehi, Contact, 210-567-6691, [email protected]
Jennifer Foster, MSN, Contact, 210-450-8696, [email protected]
Marzieh Salehi, MD, MS, Principal Investigator
Recruiting