NCT02072551

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

4 years

First QC Date

November 4, 2013

Last Update Submit

April 15, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Mean insulin secretion output

    Week after inclusion

Secondary Outcomes (3)

  • insulin secretion outout after arginine perfusion

    during hospitalisation (3 days)

  • sensitivity to insulin

    during hospitalisation (3 days)

  • glucago secretion output

    during hospitalisation (3 days)

Study Arms (2)

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 Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic people

You may qualify if:

  • 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

You may not qualify if:

  • Diabète induit (médicaments - ex corticoïdes) ou syndromique
  • infection
  • cancer
  • pegnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Siant-louis

Paris, 75010, France

Location

Related Publications (1)

  • Le Bourgeois F, Beltrand J, Baz B, Julla JB, Riveline JP, Simon A, Flechtner I, Ait Djoudi M, Fauret-Amsellem AL, Vial Y, Scharfmann R, Sommet J, Boudou P, Cave H, Polak M, Gautier JF, Busiah K; TNDM Long-Term Follow-Up Study Group. Long-term Metabolic and Socioeducational Outcomes of Transient Neonatal Diabetes: A Longitudinal and Cross-sectional Study. Diabetes Care. 2020 Jun;43(6):1191-1199. doi: 10.2337/dc19-0324. Epub 2020 Apr 9.

    PMID: 32273272DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

February 26, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

FR(1)