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Trial record 28 of 1393 for:    bilirubin AND alanine

Genetic Polymorphisms, Steatosis and Diabetes

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ClinicalTrials.gov Identifier: NCT02045563
Recruitment Status : Unknown
Verified December 2012 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : January 27, 2014
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment
Type 1 and 2 Diabetes Other: prise de sang Other: magnetic resonance imaging and magnetic resonance spectroscopy

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Study Type : Observational
Estimated Enrollment : 587 participants
Time Perspective: Prospective
Official Title: Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients
Estimated Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry [ Time Frame: At inclusion ]

Secondary Outcome Measures :
  1. Measurement of monocyte expression of LDL receptors [ Time Frame: At inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045563


Contacts
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Contact: Jean-Michel PETIT 3 80 29 34 53 ext +33 jean-michel.petit@chu-dijon.fr

Locations
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France
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Jean-Michel PETIT    3 80 29 34 53 ext +33    jean-michel.petit@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02045563     History of Changes
Other Study ID Numbers: PETIT PARI 2011
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: December 2012