Effect of purified fish oils in glucose regulatio

Conditions: Congenital hyperinsulinism
MedDRA version: 14.0Level: PTClassification code 10062329Term: Congenital endocrine anomalySystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2011-003633-33-GB

Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

All patients with a confirmed diagnosis of persistent CHI (with proven hyperinsulinism in the presence of hypoglycaemia) between the ages of 6 months to 11 years with or without a genetic mutation in a CHI gene, who have been clinically stable on oral anti-hypoglycaemic medication for a minimum period of 8 weeks prior to this pilot study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Children less than 6 months old
2) Unstable patients with highly variable glucose readings.
3) Children on cephalosporin, aspirin or concomitant anticoagulation therapy to avoid potential drug interactions with MAXEPA.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish that purified fish oils (MAXEPA) can be used as an adjunctive treatment in the management of Congenital Hyperinsulinism;Secondary Objective: To determine if:<br>MAXEPA is able to cause an average rise in blood sugar readings;<br>MAXEPA will reduce the frequency of hypoglycaemia;<br>Using MAXEPA as an adjunctive treatment will lead to a reduction of standard antihypoglycaemic medication doses.<br>;Primary end point(s): A significant increase in capillary/blood glucose measurements observed between times off and on treatment;Timepoint(s) of evaluation of this end point: A daily log of blood glucose measurements will be maintained by the parents. These will be reviewed at clinic visits on days 10, 23 and 44

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Reduced frequency of hypoglycaemic episodes<br>2) The ability to wean down normal antihypoglycaemic medications without increased risk of hypoglycaemia;Timepoint(s) of evaluation of this end point: Hypoglycaemic episodes will be reviewed at clinic visits on days 10, 23 and 44. The ability to wean down antihypoglycaemic medication will be evaluated at the day 10 clinic visit