Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise (Resolution)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
behavioral weight loss and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, behavioral weight loss, exercise training, hemoglobin A1c
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
behavioral weight loss and exercise
Arm Description
weight loss and exercise lifestyle intervention over a 6 month period
Outcomes
Primary Outcome Measures
Hemoglobin A1c
HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.
Secondary Outcome Measures
lipid profile
A lipid profile will be drawn before, and after the 6 month intervention
HS-C Reactive Protein
A HS-C Reactive Protein will be drawn before and after the 6 month intervention.
Aerobic Fitness
Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention
Full Information
NCT ID
NCT02065544
First Posted
February 11, 2014
Last Updated
February 18, 2014
Sponsor
University of Vermont
1. Study Identification
Unique Protocol Identification Number
NCT02065544
Brief Title
Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
Acronym
Resolution
Official Title
Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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%.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus, behavioral weight loss, exercise training, hemoglobin A1c
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
behavioral weight loss and exercise
Arm Type
Experimental
Arm Description
weight loss and exercise lifestyle intervention over a 6 month period
Intervention Type
Behavioral
Intervention Name(s)
behavioral weight loss and exercise
Intervention Description
Weight loss and exercise counseling
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
lipid profile
Description
A lipid profile will be drawn before, and after the 6 month intervention
Time Frame
6 months
Title
HS-C Reactive Protein
Description
A HS-C Reactive Protein will be drawn before and after the 6 month intervention.
Time Frame
6 months
Title
Aerobic Fitness
Description
Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A Ades, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise
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