Intensity of Exercise and Glucose Metabolism

NCT ID: NCT01649219

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-06-30

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

Keywords

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Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise intervention

3-month supervised exercise intervention 3 times per week; 60min per time.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

No intervention

Standard couselling at baseline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Diabetes Association

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl-Heinz Herzig, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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University of Oulu

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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64/2009

Identifier Type: -

Identifier Source: org_study_id