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NCT01278823 · ClinicalTrials.gov registry record · NA
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT01278823: Completed NA study, sponsored by The Cleveland Clinic.
NCT01278823 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01278823, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.
Primary Outcome
The working hypothesis for this aim is that significantly more obese T2DM patients who undergo RYGB surgery will achieve glycemic control based on a primary endpoint of an HbA1c ≤ 6.5% at 12 months, than patients managed by intensive medical therapy.
Interventions
- PROCEDURE laparoscopic roux en y gastric bypass operation
- OTHER medical management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-01 |
| Est. Completion | 2017-02-15 |
| Phase | NA |
What the finished NCT01278823 record still lists
NCT01278823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which laparoscopic roux en y gastric bypass operation is the first listed.
NCT01278823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01278823 about?
NCT01278823 is a clinical study titled "Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes". The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or ...
What is the current status of trial NCT01278823?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2011-01. Estimated completion is 2017-02-15.
What interventions are being tested in trial NCT01278823?
The interventions under investigation include: laparoscopic roux en y gastric bypass operation (PROCEDURE), medical management (OTHER).
Who is sponsoring clinical trial NCT01278823?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01278823's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 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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