NCT00992901 Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
| NCT ID | NCT00992901 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Post Bariatricsurgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2009-10 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2009-10 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Marzieh Salehi, MD, MS
PRINCIPAL INVESTIGATOR
Marzieh Salehi
Frequently Asked Questions
Who can join the NCT00992901 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post Bariatricsurgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT00992901 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT00992901 currently recruiting?
Yes, NCT00992901 is actively recruiting participants. Contact the research team at salehi@uthscsa.edu for enrollment information.
Where is the NCT00992901 trial being conducted?
This trial is being conducted at San Antonio, United States, San Antonio, United States.
Who is sponsoring the NCT00992901 clinical trial?
NCT00992901 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Marzieh Salehi, MD, MS at Marzieh Salehi. The trial plans to enroll 160 participants.