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

Type 2 Diabetes Mellitus Clinical Trial

— Resolution  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065544
• Other study ID #: CHRMS: M11-198
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: February 18, 2014
• Start date: February 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus
• Weight Loss

Intervention

Behavioral:
• behavioral weight loss and exercise
Weight loss and exercise counseling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.	6-months	No
Secondary	lipid profile	A lipid profile will be drawn before, and after the 6 month intervention	6 months	No
Secondary	HS-C Reactive Protein	A HS-C Reactive Protein will be drawn before and after the 6 month intervention.	6 months	No
Secondary	Aerobic Fitness	Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention	6 months	No