How better blood sugar control affects HDL ('good') cholesterol in people with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll about 80 adults with type 1 diabetes (HbA1c > 8.0%) admitted to the endocrinology department at CHU Dijon Bourgogne for intensified glycemic management, plus about 63 non-diabetic, non-dyslipidemic control participants. T1D participants will receive intensified therapy according to standard clinical practice (insulin adjustments, therapeutic education, and lifestyle/diet guidance) while blood and urine samples are collected to create a plasma/serum biobank. Laboratory analyses will examine HDL composition and functional assays to determine whether improved glycemic control restores anti-atherogenic HDL properties. Results in the T1D group will be compared to the control group using serial samples collected before and after glycemic improvement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Control group non-diabetic and non-dyslipidemic :

* A person who has giver written consent
* Fasting blood glucose \< 1,10 g/L
* Triglycerides \< 1,50 g/L (\< 1,70 mmol/L).
* HDL cholesterol \> 1,03 mmol/L (men) or \> 1,30 mmol/L (women).
* LDL cholesterol \< 1,60 g/L.

Type 1 diabetes group :

* A person who has giver written consent
* Treated type 1 diabetes (regardless of the route of insulin administration).
* HbA1c \> 8.0% (\> 64 mmol/mol).

Exclusion Criteria:

All participants :

* A person who is not enrolled in or eligible for a social security program
* A person subject to a legal protective measure (guardianship, tutorship)
* A person subject to a judicial protective measure
* Pregnant women, women in labor, or breastfeeding women
* Adults who are legally incompetent or unable to give informed consent
* Minors
* Systemic inflammatory disease
* Medications that affect lipoprotein metabolism: immunosuppressive therapy, long-term corticosteroid therapy.

Control group non-diabetic and non-dyslipidemic :

* Diabetes or use of an antidiabetic medication.
* Dyslipidemia or use of lipid-lowering medication.
* Cardiovascular disease (history of stroke, myocardial infarction, coronary artery disease).
* Kidney disease (glomerular filtration rate CKD-EPI \< 75 mL/min/1.73 m²)
* Presence of metabolic syndrome defined by the presence of at least three of the following criteria (NCEP-ATP III criteria):

  * waist circumference \> 102 cm in men, \> 88 cm in women;
  * fasting triglycerides \> 1.70 mmol/L ( \> 1.50 g/L);
  * HDL cholesterol \> 1.03 mmol/L in men and 1.29 mmol/L in women;
  * systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg;
  * fasting blood glucose ≥ 6.10 mmol/L (≥ 1.10 g/L).

Type 1 diabetes group:

* Diagnosis of type 1 diabetes within 12 months prior to enrollment.
* Glomerular filtration rate (CKD-EPI) \< 60 mL/min/1.73 m².
* Albuminuria ≥ 30 mg/g creatinine.
* Initiation of lipid-lowering therapy within the month prior to the study.

Exclusion criteria:

Type 1 diabetes group:

\- Initiation of lipid-lowering therapy during the 3 months of the study

Where it's running

• Chu Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Benjamin BOUILLET
• Email: benjamin.bouillet@chu-dijon.fr
• Phone: 03 80 29 34 53

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.