- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065544
Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise (Resolution)
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Principal Investigator: Philip A Ades, MD, University of Vermont
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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