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NCT01295229 · ClinicalTrials.gov registry record · NA
Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT01295229: Completed NA study, sponsored by University of Washington.
NCT01295229 is a NA study that has completed, run by University of Washington. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01295229, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, but its role in diabetes management and the nature of its weight-independent anti-diabetes effects are not well established because of a paucity of appropriate randomized trials, the execution of which is hindered by numerous obstacles. The investigators therefore propose a feasibility study to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.
Primary Outcome
Explore the feasibility of a set of novel methods to create an appropriate randomization cohort of patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30-40 kg/m2 who are willing to be randomized into either roux-en-Y gastric bypass (RYGB) surgery or an intensive medical/lifestyle intervention. This will be assessed by comparing the number of people recruited to the number randomized and subsequently enrolled in the study.
Interventions
- BEHAVIORAL Lifestyle Intervention
- PROCEDURE laparoscopic Roux-en-Y gastric bypass (RYGB) procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-06 |
| Phase | NA |
What the finished NCT01295229 record still lists
NCT01295229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Lifestyle Intervention is the first listed.
NCT01295229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01295229 about?
NCT01295229 is a clinical study titled "Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes". The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, ...
What is the current status of trial NCT01295229?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2011-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01295229?
The interventions under investigation include: Lifestyle Intervention (BEHAVIORAL), laparoscopic Roux-en-Y gastric bypass (RYGB) procedure (PROCEDURE).
Who is sponsoring clinical trial NCT01295229?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01295229's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 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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