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NCT02328599 · ClinicalTrials.gov registry record
Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes
A clinical trial, sponsored by Ali Aminian.
- Completed
- Registry status
- 262
- Enrollment target
NCT02328599: Completed study, sponsored by Ali Aminian.
NCT02328599 is a clinical trial that has completed, run by Ali Aminian. The registered enrollment target is 262 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02328599 has completed, sponsored by Ali Aminian.
- COMPLETED
- Registry status
- 262 participants
- Enrollment target
Study Summary
Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years. Following this, a consortium was created to pool data and continue to follow study participants. This early collaboration of the 4 groups of investigators was supported by Industry sponsors (Ethicon, Inc and Medtronic-MITG). Now, the investigators have successfully received a grant from the NIH, as the sole supporter of continued observational follow-up of study participants. The continuing aim of this study is to combine data from the 4 studies and follow the original randomized subjects for an additional 5 years of follow-up. The purpose of the study is to determine the longer term durability and effectiveness of bariatric surgery compared to medical/lifestyle intervention on the treatment of type 2 diabetes.
Primary Outcome
Between group (medical vs. surgical) in HbA1c from baseline to 7 year for all participants and up to 13 years for the earliest enrollees
Interventions
- PROCEDURE Bariatric surgery involving Roux-en-Y gastric bypass
- PROCEDURE Bariatric surgery involving Laparoscopic adjustable gastric banding
- PROCEDURE Bariatric surgery involving Laparoscopic sleeve gastrectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2024-02-27 |
What the finished NCT02328599 record still lists
NCT02328599 is an observational study that tracks outcomes without assigning an intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Bariatric surgery involving Roux-en-Y gastric bypass is the first listed.
NCT02328599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02328599 about?
NCT02328599 is a clinical study titled "Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes". Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years. Following this, a conso...
What is the current status of trial NCT02328599?
This trial is currently completed. The enrollment target is 262 participants. The study started on 2018-04-10. Estimated completion is 2024-02-27.
What interventions are being tested in trial NCT02328599?
The interventions under investigation include: Bariatric surgery involving Roux-en-Y gastric bypass (PROCEDURE), Bariatric surgery involving Laparoscopic adjustable gastric banding (PROCEDURE), Bariatric surgery involving Laparoscopic sleeve gastrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02328599?
This trial is sponsored by Ali Aminian, which has 4 total clinical trials registered on ClinicalTrials.gov.
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