KETOgenic Diet Therapy in Patients With ACROmegaly

NCT06949891 | Recruiting

• 1 other identifier: NL8384107823
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acromegaly Due to Pituitary Adenoma; Ketogenic Diet; Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• IGF-1

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

  At baseline, 3 months and 6 months.

Other Outcomes (23)

• Food intake

  At baseline, 3 months and 6 months.

• Quality of Life questionnaire

  At baseline, 3 months and 6 months.

• Quality of Life questionnaire

  At baseline, 3 months and 6 months.

Study Arms (2)

People with acromegaly following Ketogenic diet

EXPERIMENTAL

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.

Dietary Supplement: Ketogenic diet

People with acromegaly following Mediterranean diet

ACTIVE COMPARATOR

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

Dietary Supplement: Mediterranean diet

Interventions

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.

People with acromegaly following Ketogenic diet

Mediterranean diet DIETARY_SUPPLEMENT

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

People with acromegaly following Mediterranean diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015 GE, Netherlands

RECRUITING

MeSH Terms

Conditions

Growth Hormone-Secreting Pituitary Adenoma

Interventions

Diet, Ketogenic; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pituitary Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Plant-Based

Central Study Contacts

Kirsten A. Berk, Dr.

CONTACT

+31 0107033055; k.berk@erasmusmc.nl

Eline te Nijenhuis-Noort, MSc

CONTACT

+31 0107033055; l.tenijenhuis-noort@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, Assistant Professor, Department Internal Medicine - Dietetics (+31)107040567 k.berk@erasmusmc.nl Dr. Molewaterplein 40, 3015 GD Rotterdam Postbus 2040, 3000

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 29, 2025
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)