diabète de Type 1ApoC1NCT02816099
Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients
A study testing Prise de sang in people with diabète de Type 1, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down. ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- diabète de Type 1
- What is being tested?
- Prise de sang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2014to 14 Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Patients with type-1 diabetes and glycated hemoglobin (HbA1C) >9%
- Subjects over 18 years
- Normal glycaemia (Fasting glycaemia <1.10 g/L) and normal lipids (Low-density lipoproteins (LDL) <1.6 g/L, triglycerides (TG) <1.5 g/L)
Who cannot join
- Adults under guardianship
- Patients without national health insurance
- Pregnant or breast-feeding women
- Progressive cancer
- Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
- Adults under guardianship
Show all 10Show fewer
- Persons without national health insurance
- Pregnant or breast-feeding women
- known dyslipidemia and/or lipid-lowering treatment
- Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of the Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesterol Ester Transfer Protein (CETP) in Type-1 Diabetes Patients
In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.
ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.
Read more
The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.
240 persons will be recruited in this study and allocated to one of two groups:
- 160 Type-1 diabetes patients with uncontrolled diabetes:
- 4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.
- 80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.
- 4 blood samples will be taken at the time of inclusion.
- Conditions
- diabète de Type 1
- Being tested
- Prise de sang
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prise de sangBiological
| Study group | Role | What they receive |
|---|---|---|
| Type-1 diabetes patients | Experimental | Not described Receives: Biological: Prise de sang |
| Controls | Other | Not described Receives: Biological: Prise de sang |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
Measured: 3 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start20 Nov 2014
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for diabète de Type 1Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
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
- NCT02816099
- Sponsor's protocol ID
- BOUILLET AOI 2015
- Acronym
- ApoC1
- Status last verified
- Feb 2026
- First submitted
- 24 Jun 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Rouland A, Gautier T, Denimal D, Duvillard L, Simoneau I, Rageot D, Verges B, Bouillet B. The Endogenous Inhibitor of CETP, apoC1, Remains Ineffective In Vivo after Correction of Hyperglycemia in People with Type 1 Diabetes. Metabolites. 2024 Sep 7;14(9):487. doi: 10.3390/metabo14090487.
PubMed 39330494Denimal D, Monier S, Simoneau I, Duvillard L, Verges B, Bouillet B. HDL functionality in type 1 diabetes: enhancement of cholesterol efflux capacity in relationship with decreased HDL carbamylation after improvement of glycemic control. Cardiovasc Diabetol. 2022 Aug 12;21(1):154. doi: 10.1186/s12933-022-01591-9.
PubMed 35962339
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesterol Ester Transfer Protein (CETP) in Type-1 Diabetes Patients
- ClinicalTrials.gov ID
- NCT02816099
- Acronym / sponsor ID
- ApoC1 / BOUILLET AOI 2015
- Conditions
- diabète de Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Nov 2014 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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.
In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.
ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.
The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.
240 persons will be recruited in this study and allocated to one of two groups:
- 160 Type-1 diabetes patients with uncontrolled diabetes:
- 4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.
- 80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.
- 4 blood samples will be taken at the time of inclusion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type-1 diabetes patients | Experimental | Biological: Prise de sang |
| Controls | Other | Biological: Prise de sang |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years
- Patients with type-1 diabetes and glycated hemoglobin (HbA1C) >9%
- Subjects over 18 years
- Normal glycaemia (Fasting glycaemia <1.10 g/L) and normal lipids (Low-density lipoproteins (LDL) <1.6 g/L, triglycerides (TG) <1.5 g/L)
Key exclusion criteria (10 listed)
- Adults under guardianship
- Patients without national health insurance
- Pregnant or breast-feeding women
- Progressive cancer
- Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
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 |
|---|---|---|
| Prise de sang | Biological | Controls, Type-1 diabetes patients |
Primary outcome
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
Time frame: 3 mois
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 6 Feb 2026.
- Results publication: PubMed 39330494Rouland A, Gautier T, Denimal D, Duvillard L, Simoneau I, Rageot D, Verges B, Bouillet B. The Endogenous Inhibitor of CETP, apoC1, Remains Ineffective In Vivo after Correction of Hyperglycemia in People with Type 1 Diabetes. Metabolites. 2024 Sep 7;14(9):487. doi: 10.3390/metabo14090487.
- Derived from this study: PubMed 35962339Denimal D, Monier S, Simoneau I, Duvillard L, Verges B, Bouillet B. HDL functionality in type 1 diabetes: enhancement of cholesterol efflux capacity in relationship with decreased HDL carbamylation after improvement of glycemic control. Cardiovasc Diabetol. 2022 Aug 12;21(1):154. doi: 10.1186/s12933-022-01591-9.
Related trials for diabète de Type 1
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prise de sang in people with diabète de Type 1, run by Centre Hospitalier Universitaire Dijon at 2 sites 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity (time frame: 3 mois). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816099, which also lists 2 linked publications.
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 6 Feb 2026.