Skin Samples of Diabetic Patients and Healthy Volunteers Collection

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01349374

First received: May 3, 2011

Last updated: July 11, 2012

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 3, 2011
Last Updated Date	July 11, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 11, 2012)	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. [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 2 hours. ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: May 5, 2011)	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. [ Time Frame: study period (up to one year) ] [ Designated as safety issue: No ] 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.
Change History	Complete list of historical versions of study NCT01349374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Skin Samples of Diabetic Patients and Healthy Volunteers Collection
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Group1 healthy volunteers Intervention: Other: skin biopsy Experimental: group2 Unaffected siblings of MODY patients Intervention: Other: skin biopsy Experimental: Group3 Type2 Diabetic patients Intervention: Other: skin biopsy Experimental: Group4 MODY patients Intervention: Other: skin biopsy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	80
Completion Date	September 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01349374
Other Study ID Numbers ^ICMJE	2010-A01127-32
Has Data Monitoring Committee	No
Responsible Party	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Study Sponsor ^ICMJE	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top