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NCT Number: NCT06949891

KETOgenic Diet Therapy in Patients With ACROmegaly

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.

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Key information

Conditions

Acromegaly Due to Pituitary Adenoma Adenoma Brain Diseases Central Nervous System Diseases Endocrine Gland Neoplasms Endocrine System Diseases Growth Hormone-Secreting Pituitary Adenoma Hypothalamic Diseases Ketogenic Diet Mediterranean Diet Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Pituitary Diseases Pituitary Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 the normal range (xULN)) on a stable medication dose for at least 4 months
  • Written informed consent

Exclusion criteria

  • Pregnancy or breastfeeding
  • Pegvisomant treatment
  • Has undergone pituitary surgery or radiotherapy within 6 months prior to s study entry;
  • It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study;
  • History or presence of epilepsy;
  • Participation in a trail of an experimental drug or device within 30 days prior to screening;
  • Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Screening HbA1c > 6,5%;
  • Use of antidiabetic medication other than Metformin

Treatment and study plan

Ketogenic diet

Dietary Supplement

A eucaloric ketogenic diet (30-40 g carbohydrate per day) for 3 months, followed by a less strict ketogenic diet (50-60 g carbohydrate per day) for another 3 months.

Mediterranean diet

Dietary Supplement

The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet.

Primary outcomes

  1. IGF-1

    Time frame: At baseline, 3 months and 6 months.

    Difference in IGF-1 (expressed as times the upper limit of the normal range (xULN) in nmol/L) between control and intervention group.

Other outcomes

  1. Food intake

    Time frame: At baseline, 3 months and 6 months.

    Food intake (3-day food diary, via 'Eetmeter Voedingscentrum') in kcal, grams of carbohydrates, proteins, saturated fat and total fat, fibers and full-fledged diet (yes/no).

  2. Quality of Life questionnaire

    Time frame: At baseline, 3 months and 6 months.

    Quality of Life questionnaire AcroQol (Acromegaly Quality of Life questionnaire); a 5 point likertscale assessing frequency of occurrence (always [1] to never [5]) or degree of agreement (completely agree [1] to completely disagree [5]) with the statements), which assesses physical and psychological aspects of quality of life in 22 questions.

  3. Quality of Life questionnaire

    Time frame: At baseline, 3 months and 6 months.

    PASQ= QoL about symptoms (Patient-Assessed Acromegaly Symptom Questionnaire) and consists of 5 acromegaly-related symptoms (soft-tissue swelling, arthralgia, headache, excessive perspiration, and fatigue), which are measured on a scale of 0 to 8 points (a higher score indicating more severe symptoms), and a cumulative score (scale 0 to 40 points) can be calculated by adding the individual components )).

  4. Qualtity of Life questionnaire

    Time frame: At baseline, 3 months and 6 months.

    D-KETOcheck questionnaire; consist of 11 questions of the ketogenic which are measured on a scale of 0-4 points (a higher score indicating stronger agreement to the ketogenic diet) for patients in arm of Ketogenic diet.

  5. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    GH level in ug/l

  6. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    IGF1 level in nmol/l

  7. Serum Parameters

    Time frame: At baseline, 3 months and 6 months.

    Fasting plasma glucose in mmol/l

  8. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    Fasting insulin in pmol/l

  9. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    HbA1c in mmol/mol

  10. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    Total cholesterol in mmol/l

  11. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    HDL-cholesterol in mmol/l

  12. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    LDL-cholesterol in mmol/l

  13. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    Triglycerides in mmol/l

  14. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    Free fatty acids in mmol/l

  15. Serum parameters

    Time frame: At baseline, 3 months and 6 months.

    β-Hydroxybutyrate in mmol/l

  16. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Height in m

  17. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Weigth in kg

  18. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    BMI in kg/m2

  19. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Fat mass in kg and in percent

  20. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Fat free mass (skeletal muscle mass) in kg

  21. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Body water in percent

  22. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Hand grip strength in kg

  23. Anthropometry

    Time frame: At baseline, 3 months and 6 months.

    Resting energy expenditure in kcal/day.

Study contacts

Contact information is provided by the study sponsor or research team.

Eline te Nijenhuis-Noort, MSc

CONTACT

[email protected]

+31 0107033055

Kirsten A. Berk, Dr.

CONTACT

[email protected]

+31 0107033055

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: KETOACRO

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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