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Intensity of Exercise and Glucose Metabolism (PreDiabEx)

U

University of Oulu

Status and phase

Unknown
Phase 4

Conditions

Prediabetes

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01649219
64/2009

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Exercise intervention
Experimental group
Description:
3-month supervised exercise intervention 3 times per week; 60min per time.
Treatment:
Behavioral: Exercise
No intervention
No Intervention group
Description:
Standard couselling at baseline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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