Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

Conservatively Treated CHI Patients Clinical Trial

Official title:

Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01819584
• Other study ID #: SHEBA-12-9794-KM-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 24, 2013
• Last updated: March 24, 2013
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2013
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to continue follow up of conservatively treated CHI patients and to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing treatment and incidence of diabetes mellitus in the long term.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• conservatively treated CHI patients who are in remission for at least one year

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Conservatively Treated CHI Patients
• Hyperinsulinism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	presence of metabolic syndrome		5 years	No
Primary	presence and frequency of hypoglycemia and hyperglycemia.		one year	No
Secondary	incidence of diabetes mellitus		5 years	No