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NCT01197963 · ClinicalTrials.gov registry record · NA
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01197963: Clinical Trial NA study, sponsored by The University of Texas Health Science Center, Houston.
NCT01197963 is a NA study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197963, a NA study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes. The surgical procedures: 1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying. 2. ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.
Primary Outcome
Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(\<110 mg/dl) normal HbA1c (\<6%) and no need for diabetic medications.
Interventions
- PROCEDURE Sleeve Gastrectomy and Ileal transposition
- DIETARY_SUPPLEMENT dietary and medical management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-02 |
| Phase | NA |
Why NCT01197963 stopped before completion
NCT01197963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Sleeve Gastrectomy and Ileal transposition is the first listed.
NCT01197963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197963 about?
NCT01197963 is a clinical study titled "A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2". The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes. The surgical procedures: 1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying. 2. ileal transposition which involves rep...
What is the current status of trial NCT01197963?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2010-09. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01197963?
The interventions under investigation include: Sleeve Gastrectomy and Ileal transposition (PROCEDURE), dietary and medical management (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01197963?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197963's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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