KETOgenic Diet Therapy in Patients With ACROmegaly (KETOACRO)

April 25, 2025 updated by: Kirsten A Berk, RD, PhD, Erasmus Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Dietary supplement: 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.
Active Comparator: People with acromegaly following Mediterranean diet
The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet.
Dietary supplement: Mediterranean diet
The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline, 3 months and 6 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At baseline, 3 months and 6 months.
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.
At baseline, 3 months and 6 months.
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 )).
At baseline, 3 months and 6 months.
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.
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
GH level in ug/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
IGF1 level in nmol/l
At baseline, 3 months and 6 months.
Serum Parameters
Time Frame: At baseline, 3 months and 6 months.
Fasting plasma glucose in mmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
Fasting insulin in pmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
HbA1c in mmol/mol
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
Total cholesterol in mmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
HDL-cholesterol in mmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
LDL-cholesterol in mmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
Triglycerides in mmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
Free fatty acids in mmol/l
At baseline, 3 months and 6 months.
Serum parameters
Time Frame: At baseline, 3 months and 6 months.
β-Hydroxybutyrate in mmol/l
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Height in m
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Weigth in kg
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
BMI in kg/m2
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Fat mass in kg and in percent
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Fat free mass (skeletal muscle mass) in kg
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Body water in percent
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Hand grip strength in kg
At baseline, 3 months and 6 months.
Anthropometry
Time Frame: At baseline, 3 months and 6 months.
Resting energy expenditure in kcal/day.
At baseline, 3 months and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL8384107823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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