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NCT07564752Recruiting

The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes

Effect of Improved Glycemic Control on the Composition and Function of High-density Lipoproteins (HDL) in Patients With Type 1 Diabetes: a Prospective, Single-center Study. Comparison With Non-diabetic, Non-dyslipidemic Control Subjects. - HAGI-T1D Study

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
143 (estimated)
First submitted
23 Apr 2026
Start date
25 Feb 2025
Primary completion date
30 Nov 2027
Lead sponsor
Centre Hospitalier Universitaire Dijon
NCT number
NCT07564752

What you commit to

  • Study type: Observational
  • Planned participants: 143
  • From 25 Feb 2025 to the primary completion date, 30 Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medications that affect lipoprotein metabolism: immunosuppressive therapy, long-term corticosteroid therapy.
    • Control group non-diabetic and non-dyslipidemic :
  • Dyslipidemia or use of lipid-lowering medication.
  • Diagnosis of type 1 diabetes within 12 months prior to enrollment.
  • Initiation of lipid-lowering therapy within the month prior to the study.
  • \- Initiation of lipid-lowering therapy during the 3 months of the study

Other illness

  • Systemic inflammatory disease
  • Diabetes or use of an antidiabetic medication.
  • Cardiovascular disease (history of stroke, myocardial infarction, coronary artery disease).
  • Kidney disease (glomerular filtration rate CKD-EPI \< 75 mL/min/1.73 m²)
  • Type 1 diabetes group:

Lab values

  • 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:
  • Albuminuria ≥ 30 mg/g creatinine.

Other

  • 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
  • Glomerular filtration rate (CKD-EPI) \< 60 mL/min/1.73 m².

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Dijon Bourgogne
Coordinator of this site? Confirm its status
DijonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.