Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Samples of Diabetic Patients and Healthy Volunteers Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01349374
Recruitment Status : Terminated
First Posted : May 6, 2011
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Tracking Information
First Submitted Date  ICMJE May 3, 2011
First Posted Date  ICMJE May 6, 2011
Last Update Posted Date July 12, 2012
Study Start Date  ICMJE January 2011
Actual 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. ]
  • 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) ]
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: May 5, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01349374
Other Study ID Numbers  ICMJE 2010-A01127-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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