acromegaly GH-producing pituitary adenoma acromegaly GH-producing pituitary tumor
Conditions
Interventions
We aim to include 30 acromegaly patients with pasireotide-induced
hyperglycaemia, to ensure that 20 patients complete the 4-month intervention.
Subjects will be randomized 1:1 to open-label eucalori
Sponsors
Recordati
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >=18 years) Confirmed diagnosis of acromegaly (for whom surgery is not an option, or for whom surgery has failed) and with inadequately GH and/or IGF-1 control (>0.8xULN)
Exclusion criteria
Exclusion criteria: * Has undergone pituitary surgery within 6 months prior to study entry; * Has undergone radiotherapy within 2 years prior to study entry; * Patients using pasireotide at screening. * Patients who have a contraindication to metformin, sitagliptin, liraglutide, or insulin. * Diabetes mellitus type 2 patients receiving diabetic medication other than metformin or with poor glycaemic control, defined as HbA1c >=9.0% (less stringent cut-off) at screening. * Diabetes mellitus type 1. * Life-threatening diabetic ketoacidosis or diabetic hyperosmolar coma. * It is anticipated that the patient receives pituitary surgery or radiotherapy during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of effect of treatment with eucaloric very-low carbohydrate ketogenic diet or diabetes medication on glycaemic control of pasireotide: * Change in HbA1c from start core study to the end of the intervention (ketogenic diet vs standard of care) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of overall effect and sustainability of glycaemic control of pasireotide in combination with eucaloric very-low carbohydrate ketogenic diet or diabetes medication: * Change in HbA1c from randomisation (start pasireotide) until the end of the core study. * Proportion of patients that achieve targets for glycemic control without glucose lowering drugs (only metformine allowed) (defined as HbA1c | — |
Countries
Netherlands
Contacts
Public ContactL.C. Nijenhuis-Noort
Leids Universitair Medisch Centrum
Outcome results
None listed