Skin Samples of Diabetic Patients and Healthy Volunteers Collection

NCT01349374 | Terminated

• 1 other identifier: 2010-A01127-32
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Group1

EXPERIMENTAL

healthy volunteers

Other: skin biopsy

group2

EXPERIMENTAL

Unaffected siblings of MODY patients

Other: skin biopsy

Group3

EXPERIMENTAL

Type2 Diabetic patients

Other: skin biopsy

Group4

EXPERIMENTAL

MODY patients

Other: skin biopsy

Interventions

skin biopsy OTHER

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.

Group1; Group3; Group4; group2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 6, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2011-05

Locations

FR (1)