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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
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 11, 2014
    Last Updated
    February 18, 2014
    Sponsor
    University of Vermont
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    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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