Effect of purified fish oils on glucose regulation

• Research type

  Research Study

• Full title

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

• IRAS ID

  63613

• Contact name

  Peter Clayton

• Sponsor organisation

  Manchester Foundation NHS Trust

• Eudract number

  2011-003633-33

• Research summary

  Congenital Hyperinsulinism (CHI) is a life-threatening disorder in children, caused by inappropriate secretion of the hormone insulin from pancreatic beta-cells. This causes uncontrolled low blood sugars (hypoglycaemia) which can lead to brain damage and death if left untreated. The inappropriate insulin release observed during times of hypoglycaemia occurs through mechanisms involving uncontrolled calcium-dependent insulin exocytosis. To date, patients with CHI have only limited treatment options to reduce/inhibit insulin secretion, some of which can only be given by injection and all of which have significant side-effects. These medications, either alone or in combination, are often unable to completely control the unregulated insulin release. Therefore, in cases of failed medical management, patients require to have major surgery involving the removal of their pancreas, which can have irreversible long-term complications. OMACOR is a licensed treatment for secondary prevention of cardiac failure following heart attack. It is composed of super-concentrated preparations of purified fish oils containing omega-3 polyunsaturated fatty acids (n-3 PUFAs). It works through the suppression of inappropriately active voltage-gated sodium ion and calcium channel activity in heart muscle cells. Recent studies also suggest that these polyunsaturated fatty acids, through similar mechanisms, can inhibit glucose-stimulated insulin release from insulin-secreting cells. We therefore aim to establish an open-label pilot study to determine if MAXEPA (purified fish oil) can be used as an additional treatment in the management of CHI, by investigating changes in blood sugar, fasting insulin and fat levels in stable CHI patients on conventional treatments, prior to and after treatment with MAXEPA for a duration of 3 weeks.Outcomes will be determined by calculating the 1) significant changes in capillary/blood sugar measurements observed between times on and off treatment; 2) reduced frequency of hypoglycaemic episodes and 3) the ability to reduce treatment of patients normal antihypoglycaemic medications without increased risk of hypoglycaemia.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0549

• Date of REC Opinion

  28 Sep 2011

• REC opinion

  Further Information Favourable Opinion