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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: behavioral weight loss and exercise


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: behavioral weight loss and exercise<br>weight loss and exercise lifestyle intervention over a 6 month period | Behavioral: behavioral weight loss and exercise<br>* Weight loss and exercise counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes. | 6-months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, behavioral weight loss, exercise training, hemoglobin A1c