Intensity of Exercise and Glucose Metabolism (PreDiabEx)

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.

Study Overview

• Status: Unknown
• Conditions: Prediabetes
• Intervention / Treatment: Behavioral: Exercise

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
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90014
    • University of Oulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise intervention; 3-month supervised exercise intervention 3 times per week; 60min per time.	Behavioral: Exercise
NO_INTERVENTION: No intervention; Standard couselling at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucose and lipid metabolism	3-month intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in muscle metabolism	3-months intervention

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital; Finnish Diabetes Association
• Investigators: Principal Investigator: Karl-Heinz Herzig, MD,PhD, University of Oulu

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ANTICIPATED): June 1, 2013

Study Registration Dates

• First Submitted: July 21, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (ESTIMATE): July 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism.
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 64/2009