Skin Samples of Diabetic Patients and Healthy Volunteers Collection

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01349374
• Other study ID #: 2010-A01127-32
• Status: Terminated
• Phase: N/A
• First received: May 3, 2011
• Last updated: July 11, 2012
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2011
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No