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NCT00641251 · ClinicalTrials.gov registry record · NA
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
A NA study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT00641251 is a NA study that has completed, run by Medtronic - MITG. The registered enrollment target is 120 participants.
The verdict
NCT00641251, a NA study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.
Interventions
- OTHER intensive medical management
- OTHER RYGB & IMM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-02 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00641251
The ClinicalTrials.gov registry entry for NCT00641251 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic - MITG, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which intensive medical management is the first listed.
NCT00641251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00641251 about?
NCT00641251 is a clinical study titled "DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery". The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versu...
What is the current status of trial NCT00641251?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2008-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00641251?
The interventions under investigation include: intensive medical management (OTHER), RYGB & IMM (OTHER).
Who is sponsoring clinical trial NCT00641251?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
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