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Completed

NCT Number: NCT02065544

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

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%.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral weight loss and exercise

Behavioral

Weight loss and exercise counseling

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6-months

    HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes.

Secondary outcomes

  1. lipid profile

    Time frame: 6 months

    A lipid profile will be drawn before, and after the 6 month intervention

  2. HS-C Reactive Protein

    Time frame: 6 months

    A HS-C Reactive Protein will be drawn before and after the 6 month intervention.

  3. Aerobic Fitness

    Time frame: 6 months

    Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Acronym: Resolution

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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