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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: behavioral weight loss and exercise

• Registration Number: NCT02065544
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study Start: 2012-02
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Study First Posted: 2014-02-19
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

• HBA1c >8.0
• BMI< 27

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
behavioral weight loss and exercise	behavioral weight loss and exercise	weight loss and exercise lifestyle intervention over a 6 month period

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6-months	HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.

Secondary Outcome Measures

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