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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02554669
Other study ID # papa vs pppa
Secondary ID
Status Completed
Phase N/A
First received May 23, 2015
Last updated September 17, 2015
Start date January 2013
Est. completion date June 2014

Study information

Verified date September 2015
Source Lillehammer University College
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed with hyperglycemia

Exclusion Criteria:

- Use of hypoglycemic agents or diseases directly affecting blood glucose, except of diabetes type 2 / insulin resistance

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
postprandial and postabsorptive physical activity on treadmill


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lillehammer University College University of Oslo

Outcome

Type Measure Description Time frame Safety issue
Other Change in oxygen consumption from test day to test day Measured by indirect calorimetry 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 No
Other Change in heart rate from test day to test day Measured by a heart rate sensor 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 No
Other Change in lactic acid from test day to test day measured from capillary finger sticks 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 No
Other Change in Respiratory exchange ration (RER) from test day to test day Measured by indirect calorimetry 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 No
Primary Change in interstitial glucose from test day to test day Interstitial glucose, measured by continuous glucose monitoring 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). No
Primary 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 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 No
Primary 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 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 No
Secondary Change in Blood glucose (venous samples) from test day to test day Plasma samples of venous blood 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 No
Secondary Change in triglycerides from test day to test day Plasma samples of venous blood 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 No
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