Randomized trial to assess low-carb and low-gluten diets' impact on acromegaly progression and symptoms

Acromegaly is a rare endocrine disorder characterized by chronic overproduction of growth hormone (GH), leading to elevated insulin-like growth factor 1 (IGF-1). This hormonal imbalance causes progressive disfigurement, organomegaly, and metabolic complications like insulin resistance and glucose intolerance, significantly impacting quality of life and increasing mortality risk. While surgical removal of pituitary adenomas and somatostatin analogs are primary treatments, some patients experience persistent symptoms or incomplete biochemical control. Exploring adjunctive, non-pharmacological strategies like dietary interventions could offer new avenues for managing disease progression and improving patient outcomes.

This randomized, controlled clinical trial (NCT05401084) is designed to enroll an estimated 9 participants diagnosed with acromegaly. Participants will be randomized into one of three arms: a low carbohydrate diet group, a low gluten diet group, or a standard diet control group. Each intervention arm will receive counseling, education, and support for implementing their respective dietary changes. The study duration for assessing outcomes is 8 weeks, with primary endpoints including changes in IGF-1 levels, GH levels, and acromegaly-related symptoms as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL) from baseline to the end of follow-up.

This study is a planned clinical trial, and specific results are not yet available. The trial aims to determine if dietary modifications, specifically a low carbohydrate diet or a low gluten diet, can significantly alter key biomarkers and patient-reported outcomes in individuals with acromegaly. Researchers will measure the change in insulin-like growth factor 1 (IGF-1) levels from baseline to 8 weeks, expecting to see a reduction in intervention groups. Similarly, changes in growth hormone (GH) levels will be assessed over the same 8-week timeframe. The study also intends to quantify improvements in acromegaly-related symptoms using the AcroQoL questionnaire, comparing the impact of the dietary interventions against a standard diet.

The primary objective is to evaluate if either a low carbohydrate or low gluten diet can lead to a statistically significant reduction in IGF-1 and GH levels, alongside an improvement in quality of life for acromegaly patients. The trial is estimated to complete in March 2025, at which point specific data and statistical analyses will be reported.