Type 1 DiabetesDIABSPORTNCT03139864
Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.
A study of Type 1 Diabetes, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2017to Dec 2019
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 6 and 12 years
- Tanner stage <T2
- Type 1 diabetes for more than 1 year for infants with type 1 diabetes
Who cannot join
- Tanner stage > ou = T2
- Obesity
- Hormonal disease
- Disease who prevent doing exercise
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Daniel TERRAL
About this study
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.
Read the detailed description
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.
- Conditions
- Type 1 Diabetes
- Being tested
- controlled physical activity
- Keywords
- Type 1 diabetes, Control, Physical activity, Substrate utilization, Hormonal regulation
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled physical activityProcedure or surgery
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Experimental | Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise : Receives: Procedure: controlled physical activity |
| without type 1 diabetes | Active comparator | Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise : Receives: Procedure: controlled physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise
Measurements will be carried out by indirect calorimetry and the relationship between CO2 et O2 (Metamax)
Measured: at day 1
Secondary outcomes (3)
hormonal regulation of blood glucose
insulin, glucagon, adrenaline, cortisol and growth hormone will be metered according to their half life until 2 hours after physical activity (T12, T20, T40, T60, T120)
Measured: at day 1
lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
during exercise
Measured: at day 1
Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
Comparison of curves of interstitial blood glucose measured with Freestyle®
Measured: 10 days before and 4 days after exercise of blood glucose modification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start4 Apr 2017
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel TERRAL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139864
- Sponsor's protocol ID
- CHU-0292
- Other IDs
- 2016-A01837-44
- Acronym
- DIABSPORT
- Status last verified
- Feb 2019
- First submitted
- 7 Apr 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.
- ClinicalTrials.gov ID
- NCT03139864
- Acronym / sponsor ID
- DIABSPORT / CHU-0292
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Control, Physical activity, Substrate utilization, Hormonal regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 May 2017 (actual)
- 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.
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.
Detailed description
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | Experimental | Procedure: controlled physical activityComparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise : |
| without type 1 diabetes | Active comparator | Procedure: controlled physical activityComparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise : |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 6 and 12 years
- Tanner stage <T2
- Type 1 diabetes for more than 1 year for infants with type 1 diabetes
Key exclusion criteria (4 listed)
- Tanner stage > ou = T2
- Obesity
- Hormonal disease
- Disease who prevent doing exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlled physical activityComparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise : | Procedure or surgery | type 1 diabetes, without type 1 diabetes |
Primary outcome
Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise
Time frame: at day 1
Measurements will be carried out by indirect calorimetry and the relationship between CO2 et O2 (Metamax)
3 secondary outcomes
hormonal regulation of blood glucose
Time frame: at day 1
lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
Time frame: at day 1
Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
Time frame: 10 days before and 4 days after exercise of blood glucose modification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Daniel TERRAL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise (time frame: at day 1). 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 4 Feb 2019.