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Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01819584
First Posted: March 27, 2013
Last Update Posted: March 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  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 ]

Secondary Outcome Measures:
  • incidence of diabetes mellitus [ Time Frame: 5 years ]

Other Outcome Measures:
  • presence of metabolic syndrome [ Time Frame: 5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01819584     History of Changes
Other Study ID Numbers: SHEBA-12-9794-KM-CTIL
First Submitted: March 24, 2013
First Posted: March 27, 2013
Last Update Posted: March 27, 2013
Last Verified: March 2013

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