Managing pasireotide-related high blood sugar in acromegaly with a ketogenic diet

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the effect of an eucaloric very-low carbohydrate ketogenic diet on glucose control in adults with acromegaly who experience pasireotide-induced hyperglycemia. Participants will follow the ketogenic diet for four months in addition to standard care, and changes in HbA1c will be compared to those receiving standard care alone. The trial evaluates whether dietary modification can improve diabetes-related measures without compromising acromegaly control. Primary outcome is the change in HbA1c from baseline to month four; secondary outcomes include differences in fasting glucose and other metabolic parameters. The study is sponsored by Leiden University Medical Center and will enroll participants at Leiden, Netherlands.

Why it matters

Who can join: the full rules

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.

Where it's running

• Leiden University Medical Centre
  Leiden, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Nienke R. Biermasz, Prof. dr.
• Email: n.r.biermasz@lumc.nl
• Phone: (+31)0715263082

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.