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RECRUITING Early Phase 1

Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

NCT01803451 · View on ClinicalTrials.gov ↗

Study Summary

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims. 1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp. 2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals. 3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Conditions Studied

Interventions

  • DRUG exendin-(9-39)
  • DRUG exendin -(9-39)

Study Locations (2)

Texas

  • Texas Diabetes Institute - University Health System — San Antonio
  • South Texas Veterans Health Care System — San Antonio

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2005-11
Est. Completion 2027-08
Phase Early Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01803451

The ClinicalTrials.gov registry entry for NCT01803451 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 481 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Post-bariatric Surgery appearing as the primary indexed condition, and to 2 interventions — of which exendin-(9-39) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01803451 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01803451 about?

NCT01803451 is a clinical study titled "Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass". The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, ter...

What is the current status of trial NCT01803451?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2005-11. Estimated completion is 2027-08.

What conditions does trial NCT01803451 study?

This clinical trial studies the following conditions: Post-bariatric Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01803451?

The interventions under investigation include: exendin-(9-39) (DRUG), exendin -(9-39) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01803451?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 481 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01803451 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial