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

August 26, 2015 updated by: Inland Norway University of Applied Sciences

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
maintain usual physical activity patterns
Experimental: Intervention
Addition of daily postprandial physical activity in addition to usual activity patterns
Behavioral: Postprandial physical activity
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inland Norway University of Applied Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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