Study in Leucocytes From Patients With Type 1 and Type 2 Diabetes Genetic Markers of Inflammation and Oxidative Stress (TÉLOMÈRES/ CANDIDATE GENES) According to the Type A or Type B Behavior Profile (Diatolepsy)

February 20, 2024 updated by: Centre Hospitalier Universitaire Dijon

This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of 50 patients according to their behaviour type, and their adaptation to different factors of stress encountered in their lives:

  • the first group will consist of patients with a characteristic Type A behaviour profile, that is to say patients with a "proactive, impatient" behaviour pattern
  • the second group will consist of patients with a characteristic Type B behaviour profile that is to say patients with a "calm, slow" behaviour pattern The objective is to know if the different behaviour patterns are associated with distinct biological markers likely to influence the evolution of the diabetes.

Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:

  1. they will answer simple questions about their disease and then complete 3 questionnaires each with 14 items.
  2. they will meet a clinical psychologist for an interview lasting approximately 45 minutes recorded on an audio recorder. The consultation will be used to seek links between the psyche and the disease.
  3. they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the morning.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have provided written informed consent
  • Patients with type 1 or type 2 diabetes
  • Patient admitted for a consultation, as out or in-patients to the Endocrinology-Diabetology-Metabolic diseases department of Dijon CHU
  • Patient > 18 years
  • Patient with either a characteristic Type A behaviour profile (Bortner > 210), or a characteristic Type B behaviour profile (Bortner<154)

Exclusion Criteria:

  • Persons not covered by national health insurance
  • Adults under guardianship or wards of court or not intellectually independent
  • Patients without diabetes
  • Patients with a mixed A/B behaviour profile (154< Bortner score <210)
  • Pregnant or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Type A behaviour profile
Other: Blood sample of 12 ml
Other: Type B behaviour profile
Other: Blood sample of 12 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Telomere length
Time Frame: Baselines
Baselines

Secondary Outcome Measures

Outcome Measure
Time Frame
Level of expression of candidate genes
Time Frame: Baselines
Baselines

Other Outcome Measures

Outcome Measure
Time Frame
Complications of diabetes (Nephropathy, Retinopathy, Neuropathy, Coronaropathy)
Time Frame: Baselines
Baselines
Scores on psychiatric/psychological scales
Time Frame: Baselines
Baselines
Analysis of the specific psychological interview EMIC
Time Frame: Baselines
Baselines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2014

Primary Completion (Actual)

May 29, 2018

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimated)

March 6, 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

Other Study ID Numbers

  • CHAUVET-GELINIER APJ 2013

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.

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