DiabetesNCT02587780
Blood Sugar Responses by Physical Activity Level and Intensity
An observational study of Diabetes, run by Small Changes.
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. Read more about this study
- Who is it for?
- Ages 19 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals (non-diabetic or other chronic disabling conditions likely to affect blood glucose) of different habitual levels of physical activity.
Who may be able to join
- male and female.
- age:19-59
- inactive, active or very active according to criteria outlined.
Who cannot join
- Diabetics other chronic condition likely to affect blood sugar
- <19>59 age
About this study
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
This observational study is designed to examine the glycaemic responses (of sedentary, active and very active healthy individuals) to a 50gram dose of glucose.
Read the detailed 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inactive | people who perform < 30mins.day physical activity at a 'moderate' level of intensity. | |
| Active | people who perform 30mins-60 mins.day of physical activity at a 'moderate' level of intensity. | |
| Very active | People who perform > 60 mins.day of physical activity at a >moderate level of intensity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response
blood glucose responses in sedentary, active and very active groups of men and women
Measured: One year
Secondary outcomes (4)
Body mass index
Height in metres squared divided by weight in kilograms
Measured: One year
Physical Activity duration
A questionnaire to asses daily physical activity participation
Measured: One year
Intensity of physical activity
A questionnaire assessing rating of perceived exertion
Measured: One year
Body fat percentage
percentage body fat recorded by bio-electrical impedance
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Small Changes
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Hallam University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587780
- Sponsor's protocol ID
- SBSREC1314/37
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02587780
- Acronym / sponsor ID
- SBSREC1314/37
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Small ChangesUniversity, hospital or other
- Collaborators
- Sheffield Hallam University
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is designed to examine the glycaemic responses (of sedentary, active and very active healthy individuals) to a 50gram dose of glucose.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactive | – | –people who perform < 30mins.day physical activity at a 'moderate' level of intensity. |
| Active | – | –people who perform 30mins-60 mins.day of physical activity at a 'moderate' level of intensity. |
| Very active | – | –People who perform > 60 mins.day of physical activity at a >moderate level of intensity. |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals (non-diabetic or other chronic disabling conditions likely to affect blood glucose) of different habitual levels of physical activity.
Key inclusion criteria (3 listed)
- male and female.
- age:19-59
- inactive, active or very active according to criteria outlined.
Key exclusion criteria (2 listed)
- Diabetics other chronic condition likely to affect blood sugar
- <19>59 age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood glucose response
Time frame: One year
blood glucose responses in sedentary, active and very active groups of men and women
4 secondary outcomes
Body mass index
Time frame: One year
Physical Activity duration
Time frame: One year
Intensity of physical activity
Time frame: One year
Body fat percentage
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Small Changes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.