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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control | Patients who are neither diabetic nor hypoglycemic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Biological | Performed on an empty stomach at the initial visit and then at 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Control group non-diabetic and non-dyslipidemic :
Type 1 diabetes group :
Exclusion Criteria:
All participants :
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):
Type 1 diabetes group:
Exclusion criteria:
Type 1 diabetes group:
- Initiation of lipid-lowering therapy during the 3 months of the study
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Patients with type 1 diabetes whose condition is poorly controlled
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin BOUILLET | Contact | 03 80 29 34 53 | benjamin.bouillet@chu-dijon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Dijon Bourgogne | Recruiting | Dijon | France |
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| Urine sample | Biological | Performed only during the initial visit for patients with type 1 diabetes |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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