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

NCT ID: NCT02065544

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

behavioral weight loss and exercise

weight loss and exercise lifestyle intervention over a 6 month period

Group Type: EXPERIMENTAL

behavioral weight loss and exercise

Intervention Type: BEHAVIORAL

Weight loss and exercise counseling

Interventions

behavioral weight loss and exercise

Weight loss and exercise counseling

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Philip Ades

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip A Ades, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Other Identifiers

CHRMS: M11-198

Identifier Type: -

Identifier Source: org_study_id