Intensity of Exercise and Glucose Metabolism (PreDiabEx)
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ClinicalTrials.gov Identifier: NCT01649219 |
Recruitment Status : Unknown
Verified July 2012 by University of Oulu.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prediabetes | Behavioral: Exercise | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | June 2010 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Exercise intervention
3-month supervised exercise intervention 3 times per week; 60min per time.
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Behavioral: Exercise |
No Intervention: No intervention
Standard couselling at baseline
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- Glucose and lipid metabolism [ Time Frame: 3-month intervention ]
- Changes in muscle metabolism [ Time Frame: 3-months intervention ]

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649219
Finland | |
University of Oulu | |
Oulu, Finland, 90014 |
Principal Investigator: | Karl-Heinz Herzig, MD,PhD | University of Oulu |
Responsible Party: | University of Oulu |
ClinicalTrials.gov Identifier: | NCT01649219 |
Other Study ID Numbers: |
64/2009 |
First Posted: | July 25, 2012 Key Record Dates |
Last Update Posted: | July 25, 2012 |
Last Verified: | July 2012 |
Prediabetes, objectively measured exercise, glucose and lipid metabolism, dose response, muscle metabolism. |
Prediabetic State Glucose Intolerance Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperglycemia |