Trial record 2 of 3 for:    "6q24-related transient neonatal diabetes mellitus" OR "neonatal diabetes"

Future of Beta Cells in Adults With Genetic Abnormality Behind Neonatal Diabetes (GLUCONEO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02072551
First received: November 4, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

The main objective of this study is to evaluate Beta cells in patients with a neonotal diabetes linked to a genetic abnormality Metabolic caracteristics will described using a transversal cohort study.


Condition
Diabetes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Devenir au Long Cours de la Cellule bêta Chez Les Adultes Porteurs d'Anomalies génétiques à l'Origine du Diabète Néonatal

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Mean insulin secretion output [ Time Frame: Week after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin secretion outout after arginine perfusion [ Time Frame: during hospitalisation (3 days) ] [ Designated as safety issue: No ]
  • sensitivity to insulin [ Time Frame: during hospitalisation (3 days) ] [ Designated as safety issue: No ]
  • glucago secretion output [ Time Frame: during hospitalisation (3 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: December 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult with neonatal diabetes
Adult with neonatal diabetes (before 1 year ) and need for insulin
non diabetic adults with a relative with neonatal diabetes

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

diabetic people

Criteria

Inclusion Criteria:

  • Age : 18 à 65 year
  • diabetic patient with a neonatal diabetis (before 1 year old) and need for insuline or patient with a relative having neonatal diabetis

Exclusion Criteria:

Diabète induit (médicaments - ex corticoïdes) ou syndromique

  • infection
  • cancer
  • pegnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072551

Contacts
Contact: Jean-François GAUTIER, MD PhD +33 1 42 49 96 87 jean-françois.gautier@sls.aphp.fr

Locations
France
Hopital Siant-louis Recruiting
Paris, France, 75010
Contact: Jean-François GAUTIER, MD PHD    +33 1 42 49 96 87    jean-françois.gautier@sls.aphp.fr   
Principal Investigator: Jean-François GAUTIER, MD PHD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02072551     History of Changes
Other Study ID Numbers: GLUCONEO
Study First Received: November 4, 2013
Last Updated: April 22, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014