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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lillehammer, Norway, 2618
        • Lillehammer University College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
maintain usual physical activity patterns
Experimental: Intervention
Addition of daily postprandial physical activity in addition to usual activity patterns
Adding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hba1c
Time Frame: Pre and post intervention which lasts an average of 12 weeks
Pre and post intervention which lasts an average of 12 weeks
Change in Fasted glucose
Time Frame: Pre and post intervention which lasts an average of 12 weeks
Pre and post intervention which lasts an average of 12 weeks
Change in 2hour glucose
Time Frame: Pre and post intervention which lasts an average of 12 weeks
Oral glucose tolerance test (OGTT)
Pre and post intervention which lasts an average of 12 weeks
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
Pre and post intervention which lasts an average of 12 weeks
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)
Measured pre and post intervention which lasts an average of 12 weeks
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
Measured pre and post intervention which lasts an average of 12 weeks
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
Measured pre and post intervention which lasts an average of 12 weeks
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)
Measured pre and post intervention which lasts an average of 12 weeks
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
Measured pre and post intervention which lasts an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total cholesterol
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
Change in LDL cholesterol
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
Change in HDL cholesterol
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
Change in triglycerides
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
Change in body weight
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
Change in waist circumference
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
Change in Blood pressure
Time Frame: Measured Pre and post intervention which lasts an average of 12 weeks
Measured Pre and post intervention which lasts an average of 12 weeks
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
Measured Pre and post intervention which lasts an average of 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured for 4 days pre intervention and 4 days in the middle of intervention
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
Measured for 4 days pre intervention and 4 days in the middle of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Estimate)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PPPA99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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