Type 1 DiabetesDID&NEPHRONCT03512132
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
An observational study of Type 1 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D). The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Blood samples and Urine sample
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2018to Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients treated in the Endocrinology, Diabetology or Nephrology departments of the CHU Dijon Bourgogne or in local nephrology or diabetology practices
Who may be able to join
- age > 18 years
- a person who has given oral consent
- Non-diabetics
- Fasting plasma glucose < 6.10 mmol/L (1.1 g/L)
- Triglyceridemia < 1.7 mmol/L (1.5 g/l)
- HDL-C concentration > 1.30 mmol/L (for women and 1.03 mmol/L for men)
Show all 25Show fewer
- Glomerular filtration flow rate > 90 mL/min/1.73m2 (These thresholds correspond to the standard thresholds for these parameters)
- age > 18 years
- a person who has given oral consent
- Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
- HbA1c between 6 and 9%.
- normal albuminuria (albumin/creatinine ratio < 2.5 mg/mmol in men and < 3.5 in women)
- glomerular filtration rate > 90 mL/min/1.73m2
- age > 18 years
- a person who has given oral consent
- Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
- HbA1c between 6 and 9%.
- Microalbuminuria (albumin/creatinine ratio > 2.5 mg/mmol in men and > 3.5 in women, and < 30 mg/mmol)
- glomerular filtration rate > 90 mL/min/1.73m2
- age > 18 years
- a person who has given oral consent
- Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
- HbA1c between 6 and 9%.
- Macroalbuminuria (albumin/creatinine ratio > 30 mg/mmol)
- glomerular filtration rate > 45 mL/min/1.73m2
Who cannot join
- Protected adult
- Patient not affiliated to a social security scheme
- Pregnant or breastfeeding woman
- Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.
- BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Laurence DUVILLARD, 03.80.29.34.53, laurence.duvillard@chu-dijon.fr
About this study
A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).
The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).
- Conditions
- Type 1 Diabetes
- Being tested
- Blood samples, Urine sample
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach
Urine sampleBiological
Urine sample on an empty stomach
| Study group | Role | What they receive |
|---|---|---|
| control | Not described Receives: Biological: Blood samples; Biological: Urine sample | |
| T1D with normal albumin levels | Not described Receives: Biological: Blood samples; Biological: Urine sample | |
| T1D with macroalbuminuria | Not described Receives: Biological: Blood samples; Biological: Urine sample | |
| T1D with microalbuminuria | Not described Receives: Biological: Blood samples; Biological: Urine sample | |
| T1D with microalbuminuria and statins | Not described Receives: Biological: Blood samples; Biological: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to induce cholesterol efflux
amount of cholesterol captured from cells expressed as %.
Measured: inclusion
Nitric oxide synthesis
variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL
Measured: inclusion
Anti-inflammatory effect
variation in the expression of adhesion molecules (VCAM-1 [vascular cell adhesion molecule 1], ICAM-1 [InterCellular Adhesion Molecule 1] and E selectin) under the influence of TNF-alpha [Tumor Necrosis Factor alpha] in the presence of HDL compared to the absence of HDL.
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start24 Apr 2018
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512132
- Sponsor's protocol ID
- DUVILLARD 2017
- Acronym
- DID&NEPHRO
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2018
- Last updated
- 19 Jul 2024
- 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
- ClinicalTrials.gov ID
- NCT03512132
- Acronym / sponsor ID
- DID&NEPHRO / DUVILLARD 2017
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Apr 2018 (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.
A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).
The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| control | – | Biological: Blood samples, Biological: Urine sample |
| T1D with normal albumin levels | – | Biological: Blood samples, Biological: Urine sample |
| T1D with macroalbuminuria | – | Biological: Blood samples, Biological: Urine sample |
| T1D with microalbuminuria | – | Biological: Blood samples, Biological: Urine sample |
| T1D with microalbuminuria and statins | – | Biological: Blood samples, Biological: Urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated in the Endocrinology, Diabetology or Nephrology departments of the CHU Dijon Bourgogne or in local nephrology or diabetology practices
Key inclusion criteria (25 listed)
- age > 18 years
- a person who has given oral consent
- Non-diabetics
- Fasting plasma glucose < 6.10 mmol/L (1.1 g/L)
- Triglyceridemia < 1.7 mmol/L (1.5 g/l)
Key exclusion criteria (5 listed)
- Protected adult
- Patient not affiliated to a social security scheme
- Pregnant or breastfeeding woman
- Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.
- BMI > 30 kg/m2
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 |
|---|---|---|
| Blood samples5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach | Biological | T1D with macroalbuminuria, T1D with microalbuminuria, T1D with microalbuminuria and statins, T1D with normal albumin levels, control |
| Urine sampleUrine sample on an empty stomach | Biological | T1D with macroalbuminuria, T1D with microalbuminuria, T1D with microalbuminuria and statins, T1D with normal albumin levels, control |
Primary outcome
Ability to induce cholesterol efflux
Time frame: inclusion
amount of cholesterol captured from cells expressed as %.
Nitric oxide synthesis
Time frame: inclusion
variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL
Anti-inflammatory effect
Time frame: inclusion
variation in the expression of adhesion molecules (VCAM-1 [vascular cell adhesion molecule 1], ICAM-1 [InterCellular Adhesion Molecule 1] and E selectin) under the influence of TNF-alpha [Tumor Necrosis Factor alpha] in the presence of HDL compared to the absence of HDL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Centre Hospitalier Universitaire Dijon 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 25 inclusion and 5 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 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to induce cholesterol efflux (time frame: inclusion). The study lists 3 primary outcomes in all. 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 19 Jul 2024.