💬In plain words
What the trial is, and whether it could suit you
Rationale: Pasireotide is a second line medical treatment for acromegaly that can add value for patients with insufficient control of disease on 1st generation SRL, or 1st generation SRL + pegvisomant. A well-known advserse effect of pasireotide is development of hyperglycemia in 50-70% of cases. Eucaloric very-low carbohydrate ketogenic diet (VLCKD) improves hemoglobin a1c (HbA1c) and fasting plasma glucose (FPG) levels and can show even a long-term effect on glucose regulation in patients with acromegaly. Moreover, the eucaloric VLCKD has improved disease control in patients with acromegaly.
Objective: The primary objective of this study is to evaluate the change in HbA1c from start of intervention (baseline of the core study) to post-four months of ketogenic diet compared to standard of care (core study) in patients developing pasireotide-induced hyperglycemia.The secondary objective
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📋 Eligibility rules (as published)
Inclusion Criteria:
All patients with acromegaly eligible for inclusion are patients in whom pasireotide is considered in the clinical setting.
* Adult patients with a confirmed diagnosis of acromegaly (for whom surgery is not an option, or for whom surgery has failed) and with either inadequately GH and/or IGF-1 control (\>0.8xULN) or active disease symptoms with first-generation SRL, or with inadequately GH and/or IGF-1 control (\>0.8xULN) or active disease symptoms on second-line medical treatments for acromegaly (pegvisomant monotherapy or combination therapy with first-generation SRL and pegvisomant or dopamine agonist, respectively), and with a baseline Hba1c \<44 mmol/L (6.2%).
* Adult patients with a confirmed diagnosis of acromegaly (for whom surgery is not an option, or for whom surgery has failed) and with either inadequately GH and/or IGF-1 control (\>0.8xULN) or active disease symptoms with first-generation SRL, or with inadequately GH and/or IGF-1 control (\>0.8xULN) or active disease symptoms on second-line medical treatments for acromegaly (pegvisomant monotherapy or combination therapy with first-generation SRL and pegvisomant or dopamine agonist, respectively), and with a baseline Hba1c ≥44 mmol/L (6.2%) and ≤64 mmol/L (8.0%) which can first be treated and stabilized with metformine prior to rescreening and baseline measurement and are eligible if they achieve a Hba1c \<44 mmol/L (6.2%).
Because of the low incidence rate of acromegaly and pasireotide use, we can offer patients that are already on chronic treatment with pasireotide and develop newly onset diabetes the interventions. Moreover, as mentioned prior, patients excluded from the interventional study at any time can participate in the observational part of the study.
* 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:
* 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.
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