Study in Leucocytes From Patients With Type 1 and Type 2... | NCT02080741

Studies
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

NCT02080741

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Terminated

Last Update Posted

Feb 9, 2026Actual

Enrollment

57Actual

Phase

Not Applicable

Conditions

Patients With Type 1 or Type 2 Diabetes
Patients With a Type A or B Behaviour Profile

Interventions

Blood sample of 12 ml

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of inclusion

Expanded Access Info

Start Date

Sep 23, 2014Actual

Primary Completion Date

May 29, 2018Actual

Completion Date

Not provided

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Description Module

Brief Summary

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:

they will answer simple questions about their disease and then complete 3 questionnaires each with 14 items.
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.
they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the morning.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type A behaviour profile	Other		Other: Blood sample of 12 ml
Type B behaviour profile	Other		Other: Blood sample of 12 ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample of 12 ml	Other		Type A behaviour profile Type B behaviour profile

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Telomere length		Baselines

Secondary Outcomes

Measure	Description	Time Frame
Level of expression of candidate genes		Baselines

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU de DIJON		Dijon		21079	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30476653	Result	Chauvet-Gelinier JC, Mosca-Boidron AL, Lemogne C, Ragot S, Forestier N, Callegarin D, Allard C, Rebai A, Bouillet B, Ponavoy E, Simoneau I, Petit JM, Bondolfi G, Callier P, Trojak B, Bonin B, Verges B. Type A competitiveness traits correlate with downregulation of c-Fos expression in patients with type 1 diabetes. Diabetes Metab. 2019 Dec;45(6):582-585. doi: 10.1016/j.diabet.2018.11.005. Epub 2018 Nov 23.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases