Acute Effects of Postabsorptive and Postprandial Physical Activity
Primary Purpose
Hyperglycemia, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
postprandial and postabsorptive physical activity on treadmill
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia focused on measuring Blood glucose (indicated by interstitial glucose), Markers of systemic inflammation
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with hyperglycemia
Exclusion Criteria:
- Use of hypoglycemic agents or diseases directly affecting blood glucose, except of diabetes type 2 / insulin resistance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Postabsorptive physical activity
Postprandial physical activity
Arm Description
No physical activity
Physical activity performed before breakfast
Physical activity performed in the postprandial period after breakfast
Outcomes
Primary Outcome Measures
Change in interstitial glucose from test day to test day
Interstitial glucose, measured by continuous glucose monitoring
Change in hsCRP from test day to test day
This is a marker of inflammation, it will be measured from plasma of venous blood samples
Change in VCAM from test day to test day
This is a marker of inflammation, it will be measured from plasma of venous blood samples
Secondary Outcome Measures
Change in Blood glucose (venous samples) from test day to test day
Plasma samples of venous blood
Change in triglycerides from test day to test day
Plasma samples of venous blood
Full Information
NCT ID
NCT02554669
First Posted
May 23, 2015
Last Updated
September 17, 2015
Sponsor
Inland Norway University of Applied Sciences
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT02554669
Brief Title
Acute Effects of Postabsorptive and Postprandial Physical Activity
Official Title
Acute Effects of Postabsorptive and Postprandial Physical Activity on Glycemia and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inland Norway University of Applied Sciences
Collaborators
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Physical activity performed in the postprandial state has the ability to blunt postprandial glycemia acutely, even as a result of very light or small amounts of postprandial physical activity. Postprandial physical activity decreases postprandial glycemia more effectively than activity performed in the post-absorptive state. However, studies comparing postprandial and postabsorptive physical activity have measured glycemic outcomes in only short periods of time (hours) or have used a very large dose of physical activity.
Physical activity have the ability to entail an acute increase in markers of systemic inflammation.Previous studies has also shown that systemic inflammation is increased during glycemic spikes, such as after a high carbohydrate load. Therefore the effect of postprandial physical activity is difficult to predict. One one hand it might increase markers of systemic inflammation. On the other hand it might decrease systemic inflammation as a result of a blunting effect on postprandial glycemia. The effect of physical activity after carbohydrate intake might therefore also differ from postabsorptive physical activity.
Purpose of the study: I) The investigators hypothesized that light physical activity performed in the post-prandial sate decrease blood glucose in a day and night cycle compared to the same activity performed in the postabsorptive state and a control day. II) To test whether postabsorptive and postprandial light physical activity do affect markers of systemic inflammation different.
12 participants diagnosed with hyperglycemia but not on hypoglycemic medication took part in a randomized cross-over trial with 3 test days. A control day with no physical activity, and two days similar to the control day except that one of them contained a one hour bout of treadmill walking prior to breakfast and the other a similar exercise bout after breakfast. Continuous glucose monitoring was performed from start of exercise / breakfast until the morning next day (at least 22 hours). Venous blood was also sampled at given timepoints (before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast. Dietary intake was individually standardized prior to and during test days.
Detailed Description
Physical activity performed in the postprandial state has the ability to blunt postprandial glycemia acutely, even as a result of very light or small amounts of postprandial physical activity. Postprandial physical activity decreases postprandial glycemia more effectively than activity performed in the post-absorptive state. However, studies comparing postprandial and postabsorptive physical activity have measured glycemic outcomes in only short periods of time (hours) or have used a very large dose of physical activity.
Physical activity have the ability to entail an acute increase in markers of systemic inflammation.Previous studies has also shown that systemic inflammation is increased during glycemic spikes, such as after a high carbohydrate load. Therefore the effect of postprandial physical activity is difficult to predict. One one hand it might increase markers of systemic inflammation. On the other hand it might decrease systemic inflammation as a result of a blunting effect on postprandial glycemia. The effect of physical activity after carbohydrate intake might therefore also differ from postabsorptive physical activity.
Purpose of the study: I) The investigators hypothesized that light physical activity performed in the post-prandial sate decrease blood glucose in a day and night cycle compared to the same activity performed in the postabsorptive state and a control day. II) To test whether postabsorptive and postprandial light physical activity do affect markers of systemic inflammation different.
12 participants diagnosed with hyperglycemia but not on hypoglycemic medication took part in a randomized cross-over trial with 3 test days. A control day with no physical activity, and two days similar to the control day except that one of them contained a one hour bout of treadmill walking prior to breakfast and the other a similar exercise bout after breakfast. Continuous glucose monitoring was performed from start of exercise / breakfast until the morning next day (at least 22 hours). Venous blood was also sampled at given timepoints (before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast. Dietary intake was individually standardized prior to and during test days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Inflammation
Keywords
Blood glucose (indicated by interstitial glucose), Markers of systemic inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No physical activity
Arm Title
Postabsorptive physical activity
Arm Type
Experimental
Arm Description
Physical activity performed before breakfast
Arm Title
Postprandial physical activity
Arm Type
Experimental
Arm Description
Physical activity performed in the postprandial period after breakfast
Intervention Type
Behavioral
Intervention Name(s)
postprandial and postabsorptive physical activity on treadmill
Primary Outcome Measure Information:
Title
Change in interstitial glucose from test day to test day
Description
Interstitial glucose, measured by continuous glucose monitoring
Time Frame
Measured continuously on each test day, but a mean of every 5. minute during test day (from breakfast until 22 hours after breakfast) is stored and used for analysis (acute effect in a cross-over design).
Title
Change in hsCRP from test day to test day
Description
This is a marker of inflammation, it will be measured from plasma of venous blood samples
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast is used for analysis of change from test day to test day
Title
Change in VCAM from test day to test day
Description
This is a marker of inflammation, it will be measured from plasma of venous blood samples
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast is used for analysis of change from test day to test day
Secondary Outcome Measure Information:
Title
Change in Blood glucose (venous samples) from test day to test day
Description
Plasma samples of venous blood
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast is used for analysis of change from test day to test day
Title
Change in triglycerides from test day to test day
Description
Plasma samples of venous blood
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples before exercise / before breakfast, and 1.5, 2.5, 3.5 and 24 hours after breakfast is used for analysis of change from test day to test day
Other Pre-specified Outcome Measures:
Title
Change in oxygen consumption from test day to test day
Description
Measured by indirect calorimetry
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples during exercise, and 1, 2 and 3 hours after breakfast is used for analysis of change from test day to test day
Title
Change in heart rate from test day to test day
Description
Measured by a heart rate sensor
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples during exercise, and 1, 2 and 3 hours after breakfast is used for analysis of change from test day to test day
Title
Change in lactic acid from test day to test day
Description
measured from capillary finger sticks
Time Frame
Measured on each test day (acute effect in a cross-over design). A sample after 59 minutes of exercise is used for analysis of difference between intervention days
Title
Change in Respiratory exchange ration (RER) from test day to test day
Description
Measured by indirect calorimetry
Time Frame
Measured on each test day (acute effect in a cross-over design). A mean of the samples during exercise, and 1, 2 and 3 hours after breakfast is used for analysis of change from test day to test day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with hyperglycemia
Exclusion Criteria:
Use of hypoglycemic agents or diseases directly affecting blood glucose, except of diabetes type 2 / insulin resistance
12. IPD Sharing Statement
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Acute Effects of Postabsorptive and Postprandial Physical Activity
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