Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01819584
First received: March 24, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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
Conservatively Treated CHI Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • presence and frequency of hypoglycemia and hyperglycemia. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of diabetes mellitus [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • presence of metabolic syndrome [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients below 15 years old
Patients above 15 years old

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study will include conservatively treated CHI patients who are in remission for at least one year

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01819584     History of Changes
Other Study ID Numbers: SHEBA-12-9794-KM-CTIL
Study First Received: March 24, 2013
Last Updated: March 24, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Hyperinsulinism
Congenital Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia

ClinicalTrials.gov processed this record on September 15, 2014