Actively Recruiting
The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes
Led by Centre Hospitalier Universitaire Dijon · Updated on 2026-05-04
143
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The HAGI-T1D study aims to determine the effect of improved glycemic control on the composition and function of high-density lipoproteins (HDL) in patients with type 1 diabetes (T1D). It requires the establishment of a biological plasma/serum bank. T1D patients hospitalized in the Endocrinology-Diabetology-Metabolic Diseases Department at the Dijon Bourgogne University Hospital for poorly controlled diabetes (defined by glycated hemoglobin HbA1c \>8.0%). The study includes a T1D group of 80 patients with unsatisfactory glycemic control, who will undergo intensified therapy in accordance with standard clinical practice (modification of insulin therapy, therapeutic education, and lifestyle and dietary guidelines). The study also includes a control group of 63 non-diabetic, non-dyslipidemic subjects enrolled based on the results of laboratory tests from the screening visit to assess whether improved glycemic control in the T1D group restores anti-atherogenic functions and HDL composition to a level comparable to that of the control group.
CONDITIONS
Official Title
The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For the control group: signed consent, fasting blood glucose less than 1.10 g/L, triglycerides less than 1.50 g/L (less than 1.70 mmol/L), HDL cholesterol above 1.03 mmol/L (men) or above 1.30 mmol/L (women), LDL cholesterol less than 1.60 g/L
- For the type 1 diabetes group: signed consent, treated type 1 diabetes regardless of insulin administration route, HbA1c above 8.0% (above 64 mmol/mol)
You will not qualify if you...
- Not enrolled in or eligible for a social security program
- Under legal protective measures such as guardianship or tutorship
- Subject to judicial protective measures
- Pregnant women, women in labor, or breastfeeding women
- Adults legally incompetent or unable to give informed consent
- Minors
- Systemic inflammatory disease
- Use of medications affecting lipoprotein metabolism including immunosuppressive therapy or long-term corticosteroid therapy
- For control group: diagnosis of diabetes or use of antidiabetic medication, dyslipidemia or use of lipid-lowering medication, cardiovascular disease history, kidney disease with glomerular filtration rate (CKD-EPI) less than 75 mL/min/1.73 m², metabolic syndrome defined by at least three specific criteria (waist circumference, triglycerides, HDL cholesterol, blood pressure, fasting blood glucose)
- For type 1 diabetes group: diagnosis of type 1 diabetes within 12 months prior to enrollment, glomerular filtration rate (CKD-EPI) less than 60 mL/min/1.73 m², albuminuria 30 mg/g creatinine or higher, started lipid-lowering therapy within one month prior to the study, initiation of lipid-lowering therapy during the 3-month study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chu Dijon Bourgogne
Dijon, France
Actively Recruiting
Research Team
B
Benjamin BOUILLET
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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