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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01649219
Other study ID # 64/2009
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received July 21, 2012
Last updated July 24, 2012
Start date January 2010
Est. completion date June 2013

Study information

Verified date July 2012
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date June 2013
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise


Locations

Country Name City State
Finland University of Oulu Oulu

Sponsors (3)

Lead Sponsor Collaborator
University of Oulu Finnish Diabetes Association, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose and lipid metabolism 3-month intervention Yes
Secondary Changes in muscle metabolism 3-months intervention Yes
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