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Completed

NCT Number: NCT02536066

Daily Physical Activity After Meals -Long Term Effects on Blood Glucose

The postprandial blood glucose concentration is an important risk factor for development of cardiovascular diseases and diabetes. Previous studies have shown that one bout of moderate or light post-meal physical activity effectively blunts the postprandial increase in blood glucose after carbohydrate intake. Pre-meal exercise does not generate such effect. Thus, the effect of exercise on postprandial glycemia depend on the timing of exercise. Even very light physical activity decreases postprandial glycemia when performed in the postprandial period. The purpose of this study was to investigate whether such activity performed each day for 12 weeks would influence blood variables related to glycemic control.

METHODS 40 subjects being ethnic Norwegians or of South Asian origin were randomized into an intervention or a control group. They were previously diagnosed as hyperglycemic, or with high risk of type 2 diabetes according to Ramachandran's risc score.

Control subjects were told to maintain their usual physical activity patterns during the study period, while the intervention subjects were instructed to undertake a minimum of 30 minutes of daily post-meal physical activity in addition to their usual activity patterns.

Venous blood samples were taken before and after the 12 week intervention period. Plasma was analyzed for HbA1c and for fasting and 2hour (OGTT) values of glucose, insulin and c-peptide. The subjects kept a physical activity diary, answered questionnaires and used accelerometers to determine the level of physical activity.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillehammer University College

Lillehammer, 2618, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hyperglycemia or high risk of type 2 diabetes due to Ramachandrans risk score

Exclusion criteria

  • Use of hypoglycemic agents and conditions directly affecting blood glucose other than hyperglycemia per s.e. / diabetes type 2

Treatment and study plan

Postprandial physical activity

Behavioral

Adding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily

Primary outcomes

  1. Change in Hba1c

    Time frame: Pre and post intervention which lasts an average of 12 weeks

  2. Change in Fasted glucose

    Time frame: Pre and post intervention which lasts an average of 12 weeks

  3. Change in 2hour glucose

    Time frame: Pre and post intervention which lasts an average of 12 weeks

    Oral glucose tolerance test (OGTT)

  4. Change in glucose during OGTT

    Time frame: Pre and post intervention which lasts an average of 12 weeks

    glucose measured by finger sticks every 15. minute during the 2hour oral glucose tolerance test

  5. Change in Physical fitness measured as heart rate during an exercise test

    Time frame: Measured pre and post intervention which lasts an average of 12 weeks

    Heart rate measured at the end of 10 minutes ergometer cycle test an given intensity (low) to moderate intensity)

  6. Change in Physical fitness measured as oxygen consumption during an exercise test

    Time frame: Measured pre and post intervention which lasts an average of 12 weeks

    measured at the end of 10 minutes ergometer cycle test an given intensity (low) by indirect calorimetry

  7. Change in Physical fitness measured as respiratory exchange rate during an exercise test

    Time frame: Measured pre and post intervention which lasts an average of 12 weeks

    Measured at the end of 10 minutes ergometer cycle test an given intensity (low), by indirect calorimetry

  8. Change in Physical fitness measured as perceived exertion during an exercise test

    Time frame: Measured pre and post intervention which lasts an average of 12 weeks

    Borg RPE scale measured at the end of 10 minutes ergometer cycle test an given intensity (low)

  9. Change in Physical fitness measured as lactic acid during an exercise test

    Time frame: Measured pre and post intervention which lasts an average of 12 weeks

    measured at the end of 10 minutes ergometer cycle test an given intensity (low) from capillary blod from a finger stick

Secondary outcomes

  1. Change in Total cholesterol

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  2. Change in LDL cholesterol

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  3. Change in HDL cholesterol

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  4. Change in triglycerides

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  5. Change in body weight

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  6. Change in waist circumference

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  7. Change in Blood pressure

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

  8. Change in Quality of life

    Time frame: Measured Pre and post intervention which lasts an average of 12 weeks

    Quality of life measured by SF36

Other outcomes

  1. Change in Level of physical activity

    Time frame: Measured for 4 days pre intervention and 4 days in the middle of intervention

    Measured by accelerometer

  2. Change in dietary habits

    Time frame: Measured for 4 days pre intervention and 4 days in the middle of intervention

    Measured by dietary registration with dietary diary and a kitchen scale

Sponsors and collaborators

Lead sponsor

Inland Norway University of Applied Sciences

Other

Collaborators

  • University of Oslo

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 31, 2015
Registry last updated
Aug 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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