RecruitingNot Applicable

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

France143 participantsStarted 2025-02-25

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells

Timeframe: Between Month 0 and Month 3

Trial details

NCT IDNCT07564752

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11

Contact for this trial

Benjamin BOUILLET

03 80 29 34 53 benjamin.bouillet@chu-dijon.fr

View on ClinicalTrials.gov More Type 1 Diabetes trials