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COMPLETED NA

Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes

NCT01073020 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 88 participants
Start Date 2010-01
Est. Completion 2016-11
Phase NA

Sponsor

Joslin Diabetes Center

87 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joslin Diabetes Center, which has 87 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01073020 reports 2 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01073020?

This trial is sponsored by Joslin Diabetes Center, which has 87 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial