NCT02536066

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

May 21, 2015

Last Update Submit

August 26, 2015

Conditions

Outcome Measures

Primary Outcomes (9)

  • Change in Hba1c

    Pre and post intervention which lasts an average of 12 weeks

  • Change in Fasted glucose

    Pre and post intervention which lasts an average of 12 weeks

  • Change in 2hour glucose

    Oral glucose tolerance test (OGTT)

    Pre and post intervention which lasts an average of 12 weeks

  • Change in glucose during OGTT

    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

    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

    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

    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

    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

    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 Outcomes (8)

  • Change in Total cholesterol

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

  • Change in LDL cholesterol

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

  • Change in HDL cholesterol

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

  • Change in triglycerides

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

  • Change in body weight

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

  • +3 more secondary outcomes

Other Outcomes (2)

  • Change in Level of physical activity

    Measured for 4 days pre intervention and 4 days in the middle of intervention

  • Change in dietary habits

    Measured for 4 days pre intervention and 4 days in the middle of intervention

Study Arms (2)

Control

NO INTERVENTION

maintain usual physical activity patterns

Intervention

EXPERIMENTAL

Addition of daily postprandial physical activity in addition to usual activity patterns

Behavioral: Postprandial physical activity

Interventions

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

Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lillehammer University College

Lillehammer, 2618, Norway

Location

Study Officials

  • håvard nygaard, msc

    Inland Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 21, 2015

First Posted

August 31, 2015

Study Start

September 1, 2010

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations