Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise (Resolution)

February 18, 2014 updated by: Philip Ades, University of Vermont
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put >50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of < 6.5%.

The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. > 50%) for individuals in the study.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • new diagnosis of type 2 diabetes since 12 months
  • BMI>27
  • HBA1c > 6.5, , 8.0

Exclusion Criteria:

  • HBA1c >8.0
  • BMI< 27

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: behavioral weight loss and exercise
weight loss and exercise lifestyle intervention over a 6 month period
Behavioral: behavioral weight loss and exercise
Weight loss and exercise counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 6-months
HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid profile
Time Frame: 6 months
A lipid profile will be drawn before, and after the 6 month intervention
6 months
HS-C Reactive Protein
Time Frame: 6 months
A HS-C Reactive Protein will be drawn before and after the 6 month intervention.
6 months
Aerobic Fitness
Time Frame: 6 months
Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Philip A Ades, MD, University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS: M11-198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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