Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

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

A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D). The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).

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

• age \> 18 years

• a person who has given oral consent

• Non-diabetics

• Fasting plasma glucose \< 6.10 mmol/L (1.1 g/L)

• Triglyceridemia \< 1.7 mmol/L (1.5 g/l)

• HDL-C concentration \> 1.30 mmol/L (for women and 1.03 mmol/L for men)

• Glomerular filtration flow rate \> 90 mL/min/1.73m2 (These thresholds correspond to the standard thresholds for these parameters)

• age \> 18 years

• a person who has given oral consent

• Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)

• HbA1c between 6 and 9%.

• normal albuminuria (albumin/creatinine ratio \< 2.5 mg/mmol in men and \< 3.5 in women)

• glomerular filtration rate \> 90 mL/min/1.73m2

• age \> 18 years

• a person who has given oral consent

• Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)

• HbA1c between 6 and 9%.

• Microalbuminuria (albumin/creatinine ratio \> 2.5 mg/mmol in men and \> 3.5 in women, and \< 30 mg/mmol)

• glomerular filtration rate \> 90 mL/min/1.73m2

• age \> 18 years

• a person who has given oral consent

• Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)

• HbA1c between 6 and 9%.

• Macroalbuminuria (albumin/creatinine ratio \> 30 mg/mmol)

• glomerular filtration rate \> 45 mL/min/1.73m2

Locations
Other Locations
France
Chu Dijon Bourogne
RECRUITING
Dijon
Time Frame
Start Date: 2018-04-24
Estimated Completion Date: 2026-04
Participants
Target number of participants: 200
Treatments
control
T1D with normal albumin levels
T1D with macroalbuminuria
T1D with microalbuminuria
T1D with microalbuminuria and statins
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Dijon

This content was sourced from clinicaltrials.gov