Intensity of Exercise and Glucose Metabolism

Study Overview
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Brief Summary
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Our aim is to investigate the effects of a 12-week structured aerobic exercise on fasting and 2 h glucose, insulin and lipid concentrations in sedentary overweight subjects in whom impaired fasting glucose and/or impaired glucose tolerance was observed for the first time.

Detailed Description
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Study type: Interventional Study design: Randomized Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations Intervention model: Parallel assignment Masking: Open label Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism Condition: Prediabetes Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min. No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits. Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.

Conditions
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Prediabetes

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prediabetes determined by 2 hr oGTT Exclusion Criteria: any functional limitation or chronic disease that might have limited the physical exercise and testing vigorous physical activity/exercise as revealed by questionnaire and physician exam

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>3-month supervised exercise intervention 3 times per week; 60min per time. | Behavioral: Exercise<br> <br> |
| No Intervention: No intervention<br>Standard couselling at baseline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose and lipid metabolism |  | 3-month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in muscle metabolism |  | 3-months intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.