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

NCT07564752 | Recruiting

• 1 other identifier: DENIMAL AOI 2023
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Between Month 0 and Month 3

Study Arms (2)

Patients with type 1 diabetes

Patients hospitalized in the Endocrinology, Diabetes, and Metabolic Diseases Department at the Dijon Bourgogne University Hospital due to poorly controlled diabetes.

Biological: Blood test; Biological: Urine sample

Control

Patients who are neither diabetic nor hypoglycemic

Biological: Blood test

Interventions

Blood test BIOLOGICAL

Performed on an empty stomach at the initial visit and then at 3 months

Control; Patients with type 1 diabetes

Urine sample BIOLOGICAL

Performed only during the initial visit for patients with type 1 diabetes

Patients with type 1 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes whose condition is poorly controlled

You may qualify if:

• 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).

You may not qualify if:

• 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):

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Benjamin BOUILLET

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 4, 2026
• Study Start: February 25, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1)