Blood Sugar Responses by Physical Activity Level and Intensity

Diabetes Clinical Trial

Official title:

An Observational Study of Incremental Area Under the Curve Values in Similar, Non-diabetic, Subjects- Undertaking Different Amounts and Intensities of Physical Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02587780
• Other study ID #: SBSREC1314/37
• Status: Not yet recruiting
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 26, 2015
• Start date: November 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Small Changes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This observational study is designed to examine the glycaemic responses (of sedentary, active and very active healthy individuals) to a 50gram dose of glucose.

Description:

3 groups of participants fulfilling the criteria for: sedentary (< 30mins phys activity p/day) active (>30 mins phys act p/day) and very active (> 60 mins phys act p.day) will be invited to attend a laboratory session on two separate occasions separated by one week and asked to: fast overnight before having a baseline and then six further capillary (finger-prick) blood samples taken over a period of two hours following consumption of 50 grams of glucose. The blood samples will produce a standard glucose 'curve' and this will be used to calculate incremental area under the curve to identify similarities or differences between the three groups responses. Hypothetically it may be that the different levels and intensities of physical activity will affect the results with active individuals producing flatter better-controlled blood sugar responses than the inactive subjects. The Null-hypothesis would be no difference in response. it is possible, for instance, that such a low-dose of glucose in an otherwise healthy group of individuals has no discernible affect on such a curve. Physical activity will be assessed by questionnaire and interview. Anthropometric measures (height, weight and body composition) will be taken using a stadiometer and bio-electrical impedance unit (Bodystat 1500, Body Stat: Isle of man UK) at the time of the laboratory measures. No participants will have data taken of any kind before they have read a participant information sheet and signed informed consent.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 59 Years

Eligibility

Inclusion Criteria:

• male and female.

• age:19-59

• inactive, active or very active according to criteria outlined.

Exclusion Criteria:

• Diabetics other chronic condition likely to affect blood sugar

• <19>59 age

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Small Changes	Sheffield Hallam University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose response	blood glucose responses in sedentary, active and very active groups of men and women	One year	No
Secondary	Body mass index	Height in metres squared divided by weight in kilograms	One year	No
Secondary	Physical Activity duration	A questionnaire to asses daily physical activity participation	One year	No
Secondary	Intensity of physical activity	A questionnaire assessing rating of perceived exertion	One year	No
Secondary	Body fat percentage	percentage body fat recorded by bio-electrical impedance	One year	No