Diabetes Mellitus, Type 1DiaDEPNCT03912012
Pilot Study DiaDEP
A study testing Iohexol renal clearance measurement, microcirculation assessment through Laser Doppler associated to iontophoresis. and Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement in people with Diabetes Mellitus, Type 1 and Type1diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
With an increased incidence of pediatric type 1 diabetes (T1D) and a decrease in age at diagnosis, children are exposed to complications such as renal impairment at a very young age. The current biomarker used to diagnose renal impairment is microalbuminuria, but it's a late marker. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type1diabetes
- What is being tested?
- Iohexol renal clearance measurement, microcirculation assessment through Laser Doppler associated to iontophoresis. and Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2019to 20 Nov 2020
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged ≥ 10 et < 18 years old
- Type 1 diabetes diagnosed more than 10 years previously.
- Written informed consent signed by both parents or legal representatives, child or adolescent's agreement.
- Health cover
Who cannot join
- Associated pathology with a potential impact on cutaneous microcirculation or renal function.
- Aspirin or other non-steroid anti-inflammatory treatment with potential impact on endothelial function in the 3 weeks preceding the visit.
- Examination with injection of contrast agent during the last 48 hours
- Smoking
- Ongoing pregnancy or breast feeding
- Hypersensitivity to acetylcholine
Show all 10Show fewer
- Contraindication to Iohexol
- Ongoing treatment with growth hormone, non-inhaled corticosteroids or anti-calcineurins;
- History of treatment with oral corticosteroids (not inhaled) more than 3 successive months regardless of seniority;
- Paracetamol treatment less than a week old;
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Femme Mère Enfant - Groupement Hospitalier Est
Bron, 69677
About this study
Official title: Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP
With an increased incidence of pediatric type 1 diabetes (T1D) and a decrease in age at diagnosis, children are exposed to complications such as renal impairment at a very young age.
The current biomarker used to diagnose renal impairment is microalbuminuria, but it's a late marker. Early screening is a major issue to reduce T1D consequences.
Read more
Early glomerular hyperfiltration (GHF) could participate in the development and progression of nephropathy. Hyperfiltration has also been associated with a systemic endothelial dysfunction and with changes in arterial stiffness, suggesting, at least to a certain extent, a state of generalized vascular dysfunction.
Diabetes is responsible for very early neurovascular dysfunctions, detectable with techniques to evaluate cutaneous neurovascular interaction. Those should help bringing to light very early microcirculation impairment, particularly precocious endothelial dysfunction (ED).
No study about correlation between GHF and ED is currently available. The hypothesis assessed is those of a strong correlation between ED and GHF in children and adolescent with a story of T1D for at least 10 years.
This pilot study should allow assessing ED's and GHF's proportions in our population, in order to conduct a larger study to prove, in a prospective way, the prognostic value of ED in the apparition of nephropathy, taking into count other factors such as diabetes duration or stability.
This measure could be included in the global evaluation of microangiopathy risk in children and then take action to prevent negative outcomes.
The second aspect of this study is the assessment of other functions and metabolisms possibly impaired in T1D: osseous microarchitecture, vitamin D status and precocious evaluation of macro angiopathy through intima media thickness measurement.
Long term diabetes in children is associated with shorter and leaner bones, despite a correct mineralization, a reduced bone density and a fracture risk increased six fold. Bone status in the population will be evaluated through the study of bones microarchitecture via HR-pQCT (High Resolution peripheral Quantitative Computed Tomography) on both tibia and radius, dual-energy X-ray absorptiometry (DXA), and bone turn over biochemical markers.
Results on bone microarchitecture in a preexisting cohort of healthy children and adolescents will be used to compare results.
- Conditions
- Diabetes Mellitus, Type 1, Type1diabetes
- Being tested
- Iohexol renal clearance measurement, microcirculation assessment through Laser Doppler associated to iontophoresis., Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement, Blood sampling, Urine sampling
- Keywords
- Diabetes mellitus type 1, Type 1 diabetes, diabetes, pediatrics, Glomerular hyperfiltration, endothelial dysfunction, children, adolescent
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iohexol renal clearance measurementDrug
intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.
microcirculation assessment through Laser Doppler associated to iontophoresis.Device
endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).
Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurementDevice
carotid ultrasound (during Day 1)
Blood samplingBiological
37 mL of blood sample will be performed at Day 1
Urine samplingBiological
The urinary collection will be done during the Day 1, on the first morning urination
High-resolution peripheral quantitative computed tomography (HR-pQCT)Device
assessment of the Body Mass Index by HR-pQCT (during the Day 1)
Dual-energy X-ray (DXA)Radiation
assessment of bone parameters by DXA (during the Day 1)
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescent with a history of type 1 diabetes | Other | Children and adolescent from 10 to 18 years old, with a history of type 1 diabetes for at least 10 years. Glomerular hyper filtration and endothelial dysfunction will be evaluate. Receives: Drug: Iohexol renal clearance measurement; Device: microcirculation assessment through Laser Doppler associated to iontophoresis.; Device: Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement; Biological: Blood sampling; Biological: Urine sampling; Device: High-resolution peripheral quantitative computed tomography (HR-pQCT); Radiation: Dual-energy X-ray (DXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2)
assessed through Iohexol renal clearance measurement
Measured: Day 1
Secondary outcomes (8)
Endothelial function in the forearm.
Endothelial function will be evaluated by the microcirculation assessment through Laser Doppler associated to iontophoresis of acetylcholine.
Measured: Day 1
Intima media thickness
The intima media thickness will be performed by Echo Doppler of both right and left common carotid
Measured: Day 1
arterial blood pressure
arterial blood pressure measurement
Measured: Day 1
Bone mass
Bone mass will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
Measured: Day 1
bone density
bone density will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
Measured: Day 1
quantization of bone mineral content
quantization of bone mineral content will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.
Measured: Day 1
Volumetric compartmental density
Volumetric compartmental density will be performed by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) on radius and tibia (Right tibia and non-dominant arm radius). (Unless there is a history of fracture for one of those bones, in which case the opposite side will be studied instead.)
Measured: Day 1
trabecular microarchitecture
trabecular microarchitecture will be performed by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) on radius and tibia (Right tibia and non-dominant arm radius). (Unless there is a history of fracture for one of those bones, in which case the opposite side will be studied instead.)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start9 Jul 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912012
- Sponsor's protocol ID
- 69HCL17_0518
- Acronym
- DiaDEP
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP
- ClinicalTrials.gov ID
- NCT03912012
- Acronym / sponsor ID
- DiaDEP / 69HCL17_0518
- Conditions
- Diabetes Mellitus, Type 1, Type1diabetes
- Keywords
- Diabetes mellitus type 1, Type 1 diabetes, diabetes, pediatrics, Glomerular hyperfiltration, endothelial dysfunction, children, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 11 Apr 2019 (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.
With an increased incidence of pediatric type 1 diabetes (T1D) and a decrease in age at diagnosis, children are exposed to complications such as renal impairment at a very young age.
The current biomarker used to diagnose renal impairment is microalbuminuria, but it's a late marker. Early screening is a major issue to reduce T1D consequences.
Early glomerular hyperfiltration (GHF) could participate in the development and progression of nephropathy. Hyperfiltration has also been associated with a systemic endothelial dysfunction and with changes in arterial stiffness, suggesting, at least to a certain extent, a state of generalized vascular dysfunction.
Diabetes is responsible for very early neurovascular dysfunctions, detectable with techniques to evaluate cutaneous neurovascular interaction. Those should help bringing to light very early microcirculation impairment, particularly precocious endothelial dysfunction (ED).
No study about correlation between GHF and ED is currently available. The hypothesis assessed is those of a strong correlation between ED and GHF in children and adolescent with a story of T1D for at least 10 years.
This pilot study should allow assessing ED's and GHF's proportions in our population, in order to conduct a larger study to prove, in a prospective way, the prognostic value of ED in the apparition of nephropathy, taking into count other factors such as diabetes duration or stability.
This measure could be included in the global evaluation of microangiopathy risk in children and then take action to prevent negative outcomes.
The second aspect of this study is the assessment of other functions and metabolisms possibly impaired in T1D: osseous microarchitecture, vitamin D status and precocious evaluation of macro angiopathy through intima media thickness measurement.
Long term diabetes in children is associated with shorter and leaner bones, despite a correct mineralization, a reduced bone density and a fracture risk increased six fold. Bone status in the population will be evaluated through the study of bones microarchitecture via HR-pQCT (High Resolution peripheral Quantitative Computed Tomography) on both tibia and radius, dual-energy X-ray absorptiometry (DXA), and bone turn over biochemical markers.
Results on bone microarchitecture in a preexisting cohort of healthy children and adolescents will be used to compare results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescent with a history of type 1 diabetes | Other | Drug: Iohexol renal clearance measurement, Device: microcirculation assessment through Laser Doppler associated to iontophoresis., Device: Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement, Biological: Blood sampling, Biological: Urine sampling, Device: High-resolution peripheral quantitative computed tomography (HR-pQCT), Radiation: Dual-energy X-ray (DXA)Children and adolescent from 10 to 18 years old, with a history of type 1 diabetes for at least 10 years. Glomerular hyper filtration and endothelial dysfunction will be evaluate. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged ≥ 10 et < 18 years old
- Type 1 diabetes diagnosed more than 10 years previously.
- Written informed consent signed by both parents or legal representatives, child or adolescent's agreement.
- Health cover
Key exclusion criteria (10 listed)
- Associated pathology with a potential impact on cutaneous microcirculation or renal function.
- Aspirin or other non-steroid anti-inflammatory treatment with potential impact on endothelial function in the 3 weeks preceding the visit.
- Examination with injection of contrast agent during the last 48 hours
- Smoking
- Ongoing pregnancy or breast feeding
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 |
|---|---|---|
| Iohexol renal clearance measurementintravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1. | Drug | Children and adolescent with a history of type 1 diabetes |
| microcirculation assessment through Laser Doppler associated to iontophoresis.endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1). | Device | Children and adolescent with a history of type 1 diabetes |
| Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurementcarotid ultrasound (during Day 1) | Device | Children and adolescent with a history of type 1 diabetes |
| Blood sampling37 mL of blood sample will be performed at Day 1 | Biological | Children and adolescent with a history of type 1 diabetes |
| Urine samplingThe urinary collection will be done during the Day 1, on the first morning urination | Biological | Children and adolescent with a history of type 1 diabetes |
| High-resolution peripheral quantitative computed tomography (HR-pQCT)assessment of the Body Mass Index by HR-pQCT (during the Day 1) | Device | Children and adolescent with a history of type 1 diabetes |
| Dual-energy X-ray (DXA)assessment of bone parameters by DXA (during the Day 1) | Radiation | Children and adolescent with a history of type 1 diabetes |
Primary outcome
Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2)
Time frame: Day 1
assessed through Iohexol renal clearance measurement
8 secondary outcomes
Endothelial function in the forearm.
Time frame: Day 1
Intima media thickness
Time frame: Day 1
arterial blood pressure
Time frame: Day 1
Bone mass
Time frame: Day 1
bone density
Time frame: Day 1
quantization of bone mineral content
Time frame: Day 1
Volumetric compartmental density
Time frame: Day 1
trabecular microarchitecture
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iohexol renal clearance measurement, microcirculation assessment through Laser Doppler associated to iontophoresis. and Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement in people with Diabetes Mellitus, Type 1 and Type1diabetes, run by Hospices Civils de Lyon 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2) (time frame: 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 28 Feb 2024.