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NCT01073020 · ClinicalTrials.gov registry record · NA
Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes
A NA study of Obesity and Type 2 Diabetes Mellitus, sponsored by Joslin Diabetes Center.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 2
- Study locations
NCT01073020 is a NA study of Obesity and Type 2 Diabetes Mellitus that has completed, run by Joslin Diabetes Center. The registered enrollment target is 88 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01073020, a NA study of Obesity and Type 2 Diabetes Mellitus, has completed, sponsored by Joslin Diabetes Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 2
- Study locations
Study Summary
There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effects on insulin secretion and insulin action than that expected from weight loss alone, which has led to the recent claim that such procedures may be useful as a primary treatment for T2DM in the moderately obese population. Concurrently, there have also been substantial advances in the non-surgical medical management of T2DM. As a result, the best treatment algorithm for T2DM patients with class 1 \& 2 obesity is increasingly controversial. This trial investigates the utility of currently practiced and available bariatric surgical procedures as compared with multidisciplinary intensive medical and weight management for the treatment of T2DM with class 1 and 2 obesity.
Conditions Studied
Interventions
- DEVICE Allergan Adjustable Gastric Band Surgery
- OTHER Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group
- PROCEDURE Roux-en-Y Gastric Bypass (RYGB) Surgery
- OTHER Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Joslin Diabetes Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01073020
The ClinicalTrials.gov registry entry for NCT01073020 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (89% lower). The listed sponsor is Joslin Diabetes Center, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Allergan Adjustable Gastric Band Surgery is the first listed.
NCT01073020 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01073020 about?
NCT01073020 is a clinical study titled "Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes". There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effec...
What is the current status of trial NCT01073020?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2010-01. Estimated completion is 2016-11.
What conditions does trial NCT01073020 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01073020?
The interventions under investigation include: Allergan Adjustable Gastric Band Surgery (DEVICE), Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group (OTHER), Roux-en-Y Gastric Bypass (RYGB) Surgery (PROCEDURE), Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group (OTHER).
Who is sponsoring clinical trial NCT01073020?
This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01073020 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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