Inflammation Clinical Trial
Official title:
Acute Effects of Postabsorptive and Postprandial Physical Activity on Glycemia and Inflammation
Verified date | September 2015 |
Source | Lillehammer University College |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Regional Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lillehammer University College | University of Oslo |
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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