KETOgenic Diet Therapy in Patients With ACROmegaly

NCT ID: NCT06949891

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2028-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

People with acromegaly following Ketogenic diet

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.

Group Type: EXPERIMENTAL

Ketogenic diet

Intervention Type: 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 Mediterranean diet

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

Group Type: ACTIVE_COMPARATOR

Mediterranean diet

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Ketogenic diet

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.

Intervention Type: DIETARY_SUPPLEMENT

Mediterranean diet

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kirsten A Berk, RD, PhD

Senior Researcher, Assistant Professor, Department Internal Medicine - Dietetics (+31)107040567 k.berk@erasmusmc.nl Dr. Molewaterplein 40, 3015 GD Rotterdam Postbus 2040, 3000

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Kirsten A. Berk, Dr.

Role: CONTACT

k.berk@erasmusmc.nl

+31 0107033055

Eline te Nijenhuis-Noort, MSc

Role: CONTACT

l.tenijenhuis-noort@erasmusmc.nl

+31 0107033055

Facility Contacts

Eline te Nijenhuis-Noort, MSc

Role: primary

l.tenijenhuis-noort@erasmusmc.nl

+31-0107033055

Kirsten A. Berk, Dr.

Role: backup

k.berk@erasmusmc.nl

+31-0107033055

Other Identifiers

NL8384107823

Identifier Type: -

Identifier Source: org_study_id