Effect of purified fish oils in glucose regulation

The effect of purified fish oils on glucose regulation in Congenital Hyperinsulinism of Infancy (CHI) - Effect of purified fish oils on glucose regulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003633-33-GB

Enrollment

Registered

2011-09-06

Start date

2011-09-29

Completion date

Unknown

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital hyperinsulinism MedDRA version: 14.0 Level: PT Classification code 10062329 Term: Congenital endocrine anomaly System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: MAXEPA Product Name: MaxEPA liquid Product Code: Not applicable Pharmaceutical Form: Oral liquid INN or Proposed INN: Eicosapentaenoic acid CAS Number: 10417-94-4 Concentration unit: mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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: MAXEPA is able to cause an average rise in blood sugar readings; MAXEPA will reduce the frequency of hypoglycaemia; Using MAXEPA as an adjunctive treatment will lead to a reduction of standard antihypoglycaemic medication doses. ;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	—

Measure

Time frame

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: MAXEPA is able to cause an average rise in blood sugar readings; MAXEPA will reduce the frequency of hypoglycaemia; Using MAXEPA as an adjunctive treatment will lead to a reduction of standard antihypoglycaemic medication doses. ;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

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Secondary

Measure	Time frame
Secondary end point(s): 1) Reduced frequency of hypoglycaemic episodes 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	—

Measure

Time frame

Secondary end point(s): 1) Reduced frequency of hypoglycaemic episodes 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

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Countries

United Kingdom

Contacts

Public ContactResearch Office

Central Manchester University Hospitals NHS Foundation Trust

research.secretary@cmft.nhs.uk+4401612763565

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026