No phaseRecruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet (PasiAcroKeto)
'Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Eucaloric Very-low Carbohydrate Ketogenic Diet Versus Diabetes Medication: a Multicentre, Randomized, Open-label Proof-of-concept Study'
- Sponsor
- Leiden University Medical Center (Academic or other)
- Enrollment
- 30 planned
- Conditions
- Acromegaly Due to Pituitary Adenoma; Hyperglycemia; Ketogenic Diet; Standard Care Control
- Interventions
- Ketogenic diet; Diabetes Medication
- Ages
- adults, older adults
- Registry
- NCT07866846
Full record on ClinicalTrials.gov
From the registry
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 objectives are to evaluate: * Differences between eucaloric very-low carbohydrate ketogenic diet and standard of care (diabetes medication) regarding: * Proportion of patients with target HbA1c…
Primary outcomes
- Hemoglobin A1c (HbA1c) level
History
Study completion expected
Primary completion expected
Registered
Started