Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06949891

KETOgenic Diet Therapy in Patients With ACROmegaly

Led by Erasmus Medical Center · Updated on 2025-04-29

60

Participants Needed

1

Research Sites

256 weeks

Total Duration

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AI-Summary

What this Trial Is About

Acromegaly is caused by a tumour located at the base of the brain in the pituitary gland that produces too much growth hormone (GH). Symptoms caused by the excess of GH, and consequently increased insulin like growth factor 1 (IGF-1), are disproportionate growth of body parts, fluid retention, snoring and excessive perspiration. The various metabolic changes that occur due to acromegaly increase the risk for insulin resistance, diabetes mellitus, arterial hypertension, sleep apnoea and thus an increased risk of cardiovascular disease if left untreated. The result is signs and symptoms, increased mortality, morbidity, and greatly reduced quality of life (QoL). Normalisation of GH and IGF-1 gives a normalisation of mortality, however morbidity and QoL do not (completely) normalise. After surgery, a somatostatin analogue is the primary medical treatment, however, normalisation occurs in only 40% of patients. Recently, in a proof-of-principle study, the researchers showed that a 2-week ketogenic diet (low in carbohydrates) in patients with somatostatin analogues could significantly reduce IGF-1 values. Patients felt better and sometimes even needed less somatostatin analogues. This proof of concept led to the new hypothesis that acromegaly patients with somatostatin analogues should possibly be treated with a eucaloric low-carbohydrate ketogenic diet for a longer period of time to improve their biochemistry, symptoms and QoL. Additionally, this diet can make a significant contribution in the treatment of insulin resistance and glucose intolerance that often occur in this patient group.

CONDITIONS

Official Title

KETOgenic Diet Therapy in Patients With ACROmegaly

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years or older
  • Diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor
  • IGF-I levels above 80% upper limit of normal on a stable medication dose for at least 4 months
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Treatment with pegvisomant
  • Pituitary surgery or radiotherapy within 6 months prior to study entry
  • Anticipated pituitary surgery or radiotherapy during the study
  • History or presence of epilepsy
  • Participation in a trial of an experimental drug or device within 30 days prior to screening
  • Mental condition preventing understanding of the study
  • Screening HbA1c greater than 6.5%
  • Use of antidiabetic medication other than Metformin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erasmus Medical Center

Rotterdam, Netherlands, 3015 GE

Actively Recruiting

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Research Team

K

Kirsten A. Berk, Dr.

CONTACT

E

Eline te Nijenhuis-Noort, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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