Intensity of Exercise and Glucose Metabolism (PreDiabEx)

• ClinicalTrials.gov Identifier: NCT01649219
• Recruitment Status: Unknown
• First Posted: July 25, 2012
• Last Update Posted: July 25, 2012
• Sponsor: University of Oulu
• Collaborators: Finnish Diabetes Association; Oulu University Hospital
• Information provided by (Responsible Party): University of Oulu

Tracking Information

• First Submitted Date: July 21, 2012
• First Posted Date: July 25, 2012
• Last Update Posted Date: July 25, 2012
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 24, 2012): Glucose and lipid metabolism [ Time Frame: 3-month intervention ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: July 24, 2012): Changes in muscle metabolism [ Time Frame: 3-months intervention ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intensity of Exercise and Glucose Metabolism
• Official Title: Not Provided
• Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Prediabetes
• Intervention: Behavioral: Exercise

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 24, 2012): 80
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: June 2013
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT01649219
• Other Study ID Numbers: 64/2009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Oulu
• Study Sponsor: University of Oulu

Collaborators

• Finnish Diabetes Association
• Oulu University Hospital

Investigators

• Principal Investigator: Karl-Heinz Herzig, MD,PhD; University of Oulu

• PRS Account: University of Oulu
• Verification Date: July 2012