Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism
Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01819584
Collaborator
(none)
30
32
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism
Study Start Date
:
Apr 1, 2013
Anticipated Primary Completion Date
:
Dec 1, 2014
Anticipated Study Completion Date
:
Dec 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients below 15 years old
|
|
| Patients above 15 years old
|
Outcome Measures
Primary Outcome Measures
- presence and frequency of hypoglycemia and hyperglycemia. [one year]
Secondary Outcome Measures
- incidence of diabetes mellitus [5 years]
Other Outcome Measures
- presence of metabolic syndrome [5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- conservatively treated CHI patients who are in remission for at least one year
Exclusion Criteria:
- none
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sheba Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01819584
Other Study ID Numbers:
- SHEBA-12-9794-KM-CTIL
First Posted:
Mar 27, 2013
Last Update Posted:
Mar 27, 2013
Last Verified:
Mar 1, 2013