Skin Samples of Diabetic Patients and Healthy Volunteers Collection

Study Aiming to Collect Skin Samples of Diabetic Patients and Healthy Volunteers for Cellular Reprogramming, Within the Framework of New Therapeutic Strategies in Diabetes Treatment

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: skin biopsy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Corbeil Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group1; healthy volunteers	Other: skin biopsy; 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.
EXPERIMENTAL: group2; Unaffected siblings of MODY patients	Other: skin biopsy; 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.
EXPERIMENTAL: Group3; Type2 Diabetic patients	Other: skin biopsy; 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.
EXPERIMENTAL: Group4; MODY patients	Other: skin biopsy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	patients will be followed for the duration of hospital stay, an expected average of 2 hours.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 5, 2011
• First Posted (ESTIMATE): May 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 11, 2012
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 2010-A01127-32