NCT02554669

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

May 23, 2015

Last Update Submit

September 17, 2015

Conditions

Keywords

Blood glucose (indicated by interstitial glucose)Markers of systemic inflammation

Outcome Measures

Primary Outcomes (3)

  • 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).

  • 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

  • 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

Secondary Outcomes (2)

  • Change in Blood glucose (venous samples) from test day to test day

    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

  • Change in triglycerides from test day to test day

    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 Outcomes (4)

  • Change in oxygen consumption from test day to test day

    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

  • Change in heart rate from test day to test day

    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

  • Change in lactic acid from test day to test day

    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

  • +1 more other outcomes

Study Arms (3)

Control

NO INTERVENTION

No physical activity

Postabsorptive physical activity

EXPERIMENTAL

Physical activity performed before breakfast

Behavioral: postprandial and postabsorptive physical activity on treadmill

Postprandial physical activity

EXPERIMENTAL

Physical activity performed in the postprandial period after breakfast

Behavioral: postprandial and postabsorptive physical activity on treadmill

Interventions

Postabsorptive physical activityPostprandial physical activity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with hyperglycemia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperglycemiaInflammation

Interventions

Postprandial Period

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2015

First Posted

September 18, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 18, 2015

Record last verified: 2015-09