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NCT00992901 · ClinicalTrials.gov registry record · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
A Early Phase 1 study of Hypoglycemia and Post Bariatricsurgery, sponsored by The University of Texas Health Science Center at San Antonio.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 160
- Enrollment target
- 2
- Study locations
NCT00992901 is a Early Phase 1 study of Hypoglycemia and Post Bariatricsurgery that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 160 participants, below the 503-participant average among 40 other Hypoglycemia trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00992901, a Early Phase 1 study of Hypoglycemia and Post Bariatricsurgery, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 160 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Exendin-(9-39)
- DRUG Atropine
- DRUG GLP-1 and GIP
Study Locations (2)
Texas
- Texas Diabetes Institute - University Health System - San Antonio
- South Texas Veterans Health Care System - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2009-10 |
| Est. Completion | 2027-08 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00992901
The ClinicalTrials.gov registry entry for NCT00992901 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 40 other Hypoglycemia trials with a reported enrollment target (68% lower). The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypoglycemia appearing as the primary indexed condition, and to 3 interventions - of which Exendin-(9-39) is the first listed.
NCT00992901 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00992901 about?
NCT00992901 is a clinical study titled "Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery". 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. ...
What is the current status of trial NCT00992901?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 160 participants. The study started on 2009-10. Estimated completion is 2027-08.
What conditions does trial NCT00992901 study?
This clinical trial studies the following conditions: Hypoglycemia, Post Bariatricsurgery.
What interventions are being tested in trial NCT00992901?
The interventions under investigation include: Exendin-(9-39) (DRUG), Atropine (DRUG), GLP-1 and GIP (DRUG).
Who is sponsoring clinical trial NCT00992901?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00992901 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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