search
Back to results

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
Inland Norway University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 23, 2015
    Last Updated
    September 17, 2015
    Sponsor
    Inland Norway University of Applied Sciences
    Collaborators
    University of Oslo
    search

    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

    Learn more about this trial

    Acute Effects of Postabsorptive and Postprandial Physical Activity

    We'll reach out to this number within 24 hrs