Skin Samples of Diabetic Patients and Healthy Volunteers Collection

Not Applicable

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Other: skin biopsy

• Registration Number: NCT01349374
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Brief Summary

The main objective of this study is the Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-05
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Diabetic patients diagnosed for type 2 diabetes, with a BMI between 20 and 25, without familial history and known genetic cause of diabetes.
• Diabetic patients diagnosed for MODY diabetes (1, 2, 3, 4, 5 or 6), with a BMI between 20 and 25.
• Healthy volunteers, siblings of MODY patients (1, 2, 3, 4, 5 or 6).
• Healthy volunteers without familial history of diabetes.
• Patients over 18 years old.
• Patients with social insurance coverage
• Patients who signed a consent form

Exclusion Criteria

• Type 1 diabetic patients.
• Pregnant women or women who might get pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	skin biopsy	healthy volunteers
group2	skin biopsy	Unaffected siblings of MODY patients
Group3	skin biopsy	Type2 Diabetic patients
Group4	skin biopsy	MODY patients

Primary Outcome Measures

Name	Time	Method
Nothing will be measured, the aim of the study is the obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines.	patients will be followed for the duration of hospital stay, an expected average of 2 hours.	* Each patient will have a consultation at the hospital. During this consultation, if the patient agrees to participate in the study, the doctor will make him/her sign a consent form and an appointment will be scheduled with the dermatologist for the skin biopsy.; * The dermatologist will perform the skin biopsy, the sample will then be carried to the Evry genopole, where the derivation of dermal fibroblasts will be done, and the cells will then be sent to iPierian center, in California, which will take care of the obtention of cell lines.

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil Essonnes, France