- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02045563
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
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
-
-
-
Dijon, France, 21079
- CHU de Dijon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with type-1 diabetes
|
|
Patients with type-2 diabetes
|
|
Volontaires sains
|
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
Time Frame: At inclusion
|
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of monocyte expression of LDL receptors
Time Frame: At inclusion
|
At inclusion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PETIT PARI 2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 and 2 Diabetes
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Medical University of GrazCompletedHealthy | Obesity | Type 2 Diabetes Mellitus | Type 1 DiabetesAustria
-
Medtronic DiabetesWithdrawnType 1 Diabetes | Type 2 Diabetes
-
Medtronic DiabetesCompletedType 1 Diabetes | Type 2 DiabetesUnited States
-
Istanbul Medeniyet UniversityCompletedType 1 Diabetes | Type 2 DiabetesTurkey
-
LifeScanCompleted
Clinical Trials on prise de sang
-
Centre Hospitalier Universitaire DijonCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
China Medical University HospitalChina Medical University, China; Chang Gung Memorial Hospital; National Research...Unknown
-
Chang Gung Memorial HospitalChina Medical University, China; China Medical University Hospital; National... and other collaboratorsUnknown
-
Hacettepe UniversityCompletedConnective Tissue Graft HarvestingTurkey
-
Chinese University of Hong KongCompletedType 2 Diabetes | Acceptance and Commitment Therapy | Diabetes DistressHong Kong
-
Hoffmann-La RocheCompletedDiabetes Mellitus Type 1Germany
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; Stichting tegen KankerRecruitingSquamous Cell Carcinoma of Head and NeckBelgium
-
Lund UniversityCompletedAortic Valve Disorder
-
University of Sao PauloCompletedGingival Recession, Generalized