Intensity of Exercise and Glucose Metabolism

Prediabetes Clinical Trial

— PreDiabEx  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01649219
• Other study ID #: 64/2009
• 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

• Glucose Intolerance
• Prediabetes
• Prediabetic State

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