Clinical trial NCT02045563: Genetic Polymorphisms, Steatosis and Diabetes
Official title: Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 and 2 Diabetes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of type 2 diabetes over 18 subjects treated with diet alone or with oral antidiabetic glitazones outside of patients with type 1 and of age-matched healthy volunteers and sex.

Brief summary: * Our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with Type 2 diabetes.
* We also wish to evaluate more thoroughly lipid anomalies associated with the presence of steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize that hepatic steatosis is accompanied by activation of transcription factors involved in lipogenesis, notably SREBP factors. The activation of these factors could cause an increase in the expression of LDL receptors, leading to increased LDL catabolism.
* Chronological description of the study During an outpatient consultation at the endocrinology department, diabetic patients, programmed to undergo an examination to assess their diabetes will be invited to participate in the study. Once written informed consent has been provided and clinical data has been recorded, patients with type 1 or type 2 diabetes will have standard biological examination, which is systematically done in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia, Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive protein, fibrinogen).

As well as the systematic biological tests, 3 additional tubes will be taken to screen for genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1, Apolipoprotein A - II).

IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to look for the presence of liver steatosis and to measure carotid intima-media thickness.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria Type-2 diabetics:

* Type 2 diabetes
* HbA1C\>6.5%
* 27\<BMI\<55

Inclusion criteria Type-1 diabetics:

* Type 1 diabetes
* BMI\<55 Diagnosis of type-1 diabetes based on the clinical history of the patient and/or the presence of anti-glutamate decarboxylase auto antibodies and/or a plasma level of C peptide below 0,5 ng/l.

Inclusion criteria healthy volunteers:

* Non diabetic
* Alcohol consumption \< 2 glasses per day
* Without hyperglycemic treatment (corticoids, ...)
* Without liver disease (cirrhosis, hepatitis, ...)

Exclusion Criteria:

* Pacemaker
* Daily alcohol consumption above 4 glasses per day
* Patients treated with Glitazones during the 3 months preceding inclusion
* Presence of implants
* Claustrophobia
* Patient \< 18 years
* Patient under guardianship or not intellectually independent
* Pregnancy

Primary outcomes:
measure: Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry
timeFrame: At inclusion
Secondary outcomes:
measure: Measurement of monocyte expression of LDL receptors
timeFrame: At inclusion
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References: