Genetic Polymorphisms, Steatosis and Diabetes

Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients

• 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.

Study Overview

• Status: Completed
• Conditions: Type 1 and 2 Diabetes
• Intervention / Treatment: Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy

• Study Type: Observational
• Enrollment (Actual): 507

Contacts and Locations

• Study Contact: Name: Jean-Michel PETIT; Phone Number: +33 3 80 29 34 53; Email: jean-michel.petit@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type-1 diabetes	Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy
Patients with type-2 diabetes	Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy
Volontaires sains	Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry	At inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of monocyte expression of LDL receptors	At inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2007
• Primary Completion (Actual): March 25, 2015
• Study Completion (Actual): March 25, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 23, 2014
• First Posted (Estimated): January 27, 2014

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: PETIT PARI 2011