Pilot Study DiaDEP

NCT ID: NCT03912012

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2020-11-20

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.

Conditions

Diabetes Mellitus, Type 1; Type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Iohexol renal clearance measurement

Intervention Type: DRUG

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.

Intervention Type: DEVICE

endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).

Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement

Intervention Type: DEVICE

carotid ultrasound (during Day 1)

Blood sampling

Intervention Type: BIOLOGICAL

37 mL of blood sample will be performed at Day 1

Urine sampling

Intervention Type: BIOLOGICAL

The urinary collection will be done during the Day 1, on the first morning urination

High-resolution peripheral quantitative computed tomography (HR-pQCT)

Intervention Type: DEVICE

assessment of the Body Mass Index by HR-pQCT (during the Day 1)

Dual-energy X-ray (DXA)

Intervention Type: RADIATION

assessment of bone parameters by DXA (during the Day 1)

Interventions

Iohexol renal clearance measurement

intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.

Intervention Type: DRUG

microcirculation assessment through Laser Doppler associated to iontophoresis.

endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).

Intervention Type: DEVICE

Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement

carotid ultrasound (during Day 1)

Intervention Type: DEVICE

Blood sampling

37 mL of blood sample will be performed at Day 1

Intervention Type: BIOLOGICAL

Urine sampling

The urinary collection will be done during the Day 1, on the first morning urination

Intervention Type: BIOLOGICAL

High-resolution peripheral quantitative computed tomography (HR-pQCT)

assessment of the Body Mass Index by HR-pQCT (during the Day 1)

Intervention Type: DEVICE

Dual-energy X-ray (DXA)

assessment of bone parameters by DXA (during the Day 1)

Intervention Type: RADIATION

Eligibility 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
• 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;

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Femme Mère Enfant - Groupement Hospitalier Est

Bron, , France

Countries

France

Other Identifiers

69HCL17_0518

Identifier Type: -

Identifier Source: org_study_id