Clinical trial NCT02536066: Daily Physical Activity After Meals -Long Term Effects on Blood Glucose
Official title: Daily Physical Activity After Meals -Long Term Effects on Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Blood Glucose Related Variables
Lead sponsor: Inland Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2015-08-31
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hba1c
timeFrame: Pre and post intervention which lasts an average of 12 weeks
measure: Change in Fasted glucose
timeFrame: Pre and post intervention which lasts an average of 12 weeks
measure: Change in 2hour glucose
timeFrame: Pre and post intervention which lasts an average of 12 weeks
measure: Change in glucose during OGTT
timeFrame: Pre and post intervention which lasts an average of 12 weeks
measure: Change in Physical fitness measured as heart rate during an exercise test
timeFrame: Measured pre and post intervention which lasts an average of 12 weeks
measure: Change in Physical fitness measured as oxygen consumption during an exercise test
timeFrame: Measured pre and post intervention which lasts an average of 12 weeks
measure: Change in Physical fitness measured as respiratory exchange rate during an exercise test
timeFrame: Measured pre and post intervention which lasts an average of 12 weeks
measure: Change in Physical fitness measured as perceived exertion during an exercise test
timeFrame: Measured pre and post intervention which lasts an average of 12 weeks
measure: Change in Physical fitness measured as lactic acid during an exercise test
timeFrame: Measured pre and post intervention which lasts an average of 12 weeks
Secondary outcomes:
measure: Change in Total cholesterol
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in LDL cholesterol
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in HDL cholesterol
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in triglycerides
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in body weight
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in waist circumference
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in Blood pressure
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
measure: Change in Quality of life
timeFrame: Measured Pre and post intervention which lasts an average of 12 weeks
Other outcomes:
measure: Change in Level of physical activity
timeFrame: Measured for 4 days pre intervention and 4 days in the middle of intervention
measure: Change in dietary habits
timeFrame: Measured for 4 days pre intervention and 4 days in the middle of intervention
Locations:
city: Lillehammer
country: Norway
facility: Lillehammer University College
Study officials:
affiliation: Inland Norway University of Applied Sciences
name: håvard nygaard, msc
role: PRINCIPAL_INVESTIGATOR
References: