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NCT01047735 · ClinicalTrials.gov registry record · NA
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
A NA study of Obesity and Type 2 Diabetes Mellitus, sponsored by University of Pittsburgh.
- Active
- Registry status
- NA
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT01047735: Active NA study of Obesity and Type 2 Diabetes Mellitus, sponsored by University of Pittsburgh.
NCT01047735 is a NA study of Obesity and Type 2 Diabetes Mellitus that is active but no longer recruiting, run by University of Pittsburgh. The registered enrollment target is 69 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01047735, a NA study of Obesity and Type 2 Diabetes Mellitus, is active but no longer recruiting, sponsored by University of Pittsburgh.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
Conditions Studied
Interventions
- PROCEDURE Roux-en-Y Gastric Bypass Surgery
- PROCEDURE Laparoscopic Adjustable Gastric Banding
- BEHAVIORAL Lifestyle Weight Loss Intervention
Study Locations (1)
Pennsylvania
- William F Gourash - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2009-09-01 |
| Est. Completion | 2028-07-01 |
| Phase | NA |
What the registry record for NCT01047735 still lists
NCT01047735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Roux-en-Y Gastric Bypass Surgery is the first listed.
NCT01047735 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01047735 about?
NCT01047735 is a clinical study titled "The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes". This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is ...
What is the current status of trial NCT01047735?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 69 participants. The study started on 2009-09-01. Estimated completion is 2028-07-01.
What conditions does trial NCT01047735 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01047735?
The interventions under investigation include: Roux-en-Y Gastric Bypass Surgery (PROCEDURE), Laparoscopic Adjustable Gastric Banding (PROCEDURE), Lifestyle Weight Loss Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01047735?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01047735 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01047735's enrollment target sits among peer trials
69 606th of 1053 higher than 444 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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