Type 1 Diabetes (T1D) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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).

Locations
Other Locations
France
Chu Dijon Bourgogne
RECRUITING
Dijon
Contact Information
Primary
Benjamin BOUILLET
benjamin.bouillet@chu-dijon.fr
03 80 29 34 53
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2027-11
Participants
Target number of participants: 143
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Dijon

This content was sourced from clinicaltrials.gov