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Pilot Study DiaDEP (DiaDEP)

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ClinicalTrials.gov Identifier: NCT03912012
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Type1diabetes 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : January 9, 2021
Estimated Study Completion Date : January 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Children and adolescent with a history of type 1 diabetes
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.
Drug: Iohexol renal clearance measurement
intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.

Device: microcirculation assessment through Laser Doppler associated to iontophoresis.
endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).

Device: Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement
carotid ultrasound (during Day 1)

Biological: Blood sampling
37 mL of blood sample will be performed at Day 1

Biological: Urine sampling
The urinary collection will be done during the Day 1, on the first morning urination

Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)
assessment of the Body Mass Index by HR-pQCT (during the Day 1)

Radiation: Dual-energy X-ray (DXA)
assessment of bone parameters by DXA (during the Day 1)




Primary Outcome Measures :
  1. Glomerular hyper filtration (Glomerular filtration > 135 mL/min/1,73 m2) [ Time Frame: Day 1 ]
    assessed through Iohexol renal clearance measurement


Secondary Outcome Measures :
  1. Endothelial function in the forearm. [ Time Frame: Day 1 ]
    Endothelial function will be evaluated by the microcirculation assessment through Laser Doppler associated to iontophoresis of acetylcholine.

  2. Intima media thickness [ Time Frame: Day 1 ]
    The intima media thickness will be performed by Echo Doppler of both right and left common carotid

  3. arterial blood pressure [ Time Frame: Day 1 ]
    arterial blood pressure measurement

  4. Bone mass [ Time Frame: Day 1 ]
    Bone mass will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.

  5. bone density [ Time Frame: Day 1 ]
    bone density will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.

  6. quantization of bone mineral content [ Time Frame: Day 1 ]
    quantization of bone mineral content will be performed by Dual-energy X-ray absorptiometry (DXA) on both spine and whole body.

  7. Volumetric compartmental density [ Time Frame: Day 1 ]
    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.)

  8. trabecular microarchitecture [ Time Frame: Day 1 ]
    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.)



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Contraindication to Iohexol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912012


Contacts
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Contact: Aurelie Portefaix, MD, PhD 04 72 35 79 99 ext +33 aurelie.portefaix@chu-lyon.fr
Contact: Meriem EL JANI 04 27 85 77 25 ext +33 meriem.el-jani@chu-lyon.fr

Locations
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France
Hopital Femme Mère Enfant - Groupement Hospitalier Est Recruiting
Bron, France, 69677
Contact: Aurélie Portefaix, MD, PhD    04.72.35.79.99 ext +33    aurelie.portefaix@chu-lyon.fr   
Contact: Meriem El-Jani    04 27 85 77 25 ext +33    meriem.el-jani@chu-lyon.fr   
Principal Investigator: Aurélie Portefaix, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03912012     History of Changes
Other Study ID Numbers: 69HCL17_0518
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Diabetes mellitus type 1
Type 1 diabetes
diabetes
pediatrics
Glomerular hyperfiltration
endothelial dysfunction
children
adolescent
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases