- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536066
Daily Physical Activity After Meals -Long Term Effects on Blood Glucose
The postprandial blood glucose concentration is an important risk factor for development of cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate or light post-meal physical activity effectively blunts the postprandial increase in blood glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light physical activity decreases postprandial glycemia when performed in the postprandial period. The purpose of this study was to investigate whether such activity performed each day for 12 weeks would influence blood variables related to glycemic control.
METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an intervention or a control group. They were previously diagnosed as hyperglycemic, or with high risk of type 2 diabetes according to Ramachandran's risc score.
Control subjects were told to maintain their usual physical activity patterns during the study period, while the intervention subjects were instructed to undertake a minimum of 30 minutes of daily post-meal physical activity in addition to their usual activity patterns.
Venous blood samples were taken before and after the 12 week intervention period. Plasma was analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide. The subjects kept a physical activity diary, answered questionnaires and used accelerometers to determine the level of physical activity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lillehammer, Norway, 2618
- Lillehammer University College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hyperglycemia or high risk of type 2 diabetes due to Ramachandrans risk score
Exclusion Criteria:
- Use of hypoglycemic agents and conditions directly affecting blood glucose other than hyperglycemia per s.e. / diabetes type 2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
maintain usual physical activity patterns
|
|
|
Experimental: Intervention
Addition of daily postprandial physical activity in addition to usual activity patterns
|
Adding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hba1c
Time Frame: Pre and post intervention which lasts an average of 12 weeks
|
Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in Fasted glucose
Time Frame: Pre and post intervention which lasts an average of 12 weeks
|
Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in 2hour glucose
Time Frame: Pre and post intervention which lasts an average of 12 weeks
|
Oral glucose tolerance test (OGTT)
|
Pre and post intervention which lasts an average of 12 weeks
|
|
Change in glucose during OGTT
Time Frame: Pre and post intervention which lasts an average of 12 weeks
|
glucose measured by finger sticks every 15.
minute during the 2hour oral glucose tolerance test
|
Pre and post intervention which lasts an average of 12 weeks
|
|
Change in Physical fitness measured as heart rate during an exercise test
Time Frame: Measured pre and post intervention which lasts an average of 12 weeks
|
Heart rate measured at the end of 10 minutes ergometer cycle test an given intensity (low) to moderate intensity)
|
Measured pre and post intervention which lasts an average of 12 weeks
|
|
Change in Physical fitness measured as oxygen consumption during an exercise test
Time Frame: Measured pre and post intervention which lasts an average of 12 weeks
|
measured at the end of 10 minutes ergometer cycle test an given intensity (low) by indirect calorimetry
|
Measured pre and post intervention which lasts an average of 12 weeks
|
|
Change in Physical fitness measured as respiratory exchange rate during an exercise test
Time Frame: Measured pre and post intervention which lasts an average of 12 weeks
|
Measured at the end of 10 minutes ergometer cycle test an given intensity (low), by indirect calorimetry
|
Measured pre and post intervention which lasts an average of 12 weeks
|
|
Change in Physical fitness measured as perceived exertion during an exercise test
Time Frame: Measured pre and post intervention which lasts an average of 12 weeks
|
Borg RPE scale measured at the end of 10 minutes ergometer cycle test an given intensity (low)
|
Measured pre and post intervention which lasts an average of 12 weeks
|
|
Change in Physical fitness measured as lactic acid during an exercise test
Time Frame: Measured pre and post intervention which lasts an average of 12 weeks
|
measured at the end of 10 minutes ergometer cycle test an given intensity (low) from capillary blod from a finger stick
|
Measured pre and post intervention which lasts an average of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Total cholesterol
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in LDL cholesterol
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in HDL cholesterol
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in triglycerides
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in body weight
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in waist circumference
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in Blood pressure
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
|
|
Change in Quality of life
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
|
Quality of life measured by SF36
|
Measured Pre and post intervention which lasts an average of 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Level of physical activity
Time Frame: Measured for 4 days pre intervention and 4 days in the middle of intervention
|
Measured by accelerometer
|
Measured for 4 days pre intervention and 4 days in the middle of intervention
|
|
Change in dietary habits
Time Frame: Measured for 4 days pre intervention and 4 days in the middle of intervention
|
Measured by dietary registration with dietary diary and a kitchen scale
|
Measured for 4 days pre intervention and 4 days in the middle of intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PPPA99
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