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

Blood Glucose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536066
• Other study ID #: PPPA99
• Status: Completed
• Phase: N/A
• First received: May 21, 2015
• Last updated: August 26, 2015
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Lillehammer University College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Committee Norway
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Glucose
• Blood Glucose Related Variables

Intervention

Behavioral:
• Postprandial physical activity
Adding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily

Locations

Country	Name	City	State
Norway	Lillehammer University College	Lillehammer

Sponsors (2)

Lead Sponsor	Collaborator
Lillehammer University College	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Level of physical activity	Measured by accelerometer	Measured for 4 days pre intervention and 4 days in the middle of intervention	No
Other	Change in dietary habits	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	No
Primary	Change in Hba1c		Pre and post intervention which lasts an average of 12 weeks	No
Primary	Change in Fasted glucose		Pre and post intervention which lasts an average of 12 weeks	No
Primary	Change in 2hour glucose	Oral glucose tolerance test (OGTT)	Pre and post intervention which lasts an average of 12 weeks	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change in Total cholesterol		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in LDL cholesterol		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in HDL cholesterol		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in triglycerides		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in body weight		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in waist circumference		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in Blood pressure		Measured Pre and post intervention which lasts an average of 12 weeks	No
Secondary	Change in Quality of life	Quality of life measured by SF36	Measured Pre and post intervention which lasts an average of 12 weeks	No