NCT02045563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2007

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2015

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

7.4 years

First QC Date

January 21, 2014

Last Update Submit

February 20, 2024

Conditions

Type 1 and 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry

    At inclusion

Secondary Outcomes (1)

  • Measurement of monocyte expression of LDL receptors

    At inclusion

Study Arms (3)

Patients with type-1 diabetes

Other: prise de sangOther: magnetic resonance imaging and magnetic resonance spectroscopy

Patients with type-2 diabetes

Other: prise de sangOther: magnetic resonance imaging and magnetic resonance spectroscopy

Volontaires sains

Other: prise de sangOther: magnetic resonance imaging and magnetic resonance spectroscopy

Interventions

prise de sangOTHER
Patients with type-1 diabetesPatients with type-2 diabetesVolontaires sains
magnetic resonance imaging and magnetic resonance spectroscopyOTHER
Patients with type-1 diabetesPatients with type-2 diabetesVolontaires sains

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Type 2 diabetes
  • HbA1C\>6.5%
  • \<BMI\<55
  • 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.
  • Non diabetic
  • Alcohol consumption \< 2 glasses per day
  • Without hyperglycemic treatment (corticoids, ...)
  • Without liver disease (cirrhosis, hepatitis, ...)

You may not qualify if:

  • Pacemaker
  • Daily alcohol consumption above 4 glasses per day
  • Presence of implants
  • Claustrophobia
  • Patient \< 18 years
  • Patient under guardianship or not intellectually independent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 27, 2014

Study Start

October 15, 2007

Primary Completion

March 25, 2015

Study Completion

March 25, 2015

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

FR(1)