KETOgenic Diet Therapy in Patients With ACROmegaly

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06949891
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Erasmus Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acromegaly Due to Pituitary Adenoma, Ketogenic Diet, Mediterranean Diet

Arms & Interventions

Arms

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.

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.

Interventions

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.

Dietary Supplement: - Mediterranean diet

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

Contact a Trial Team

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International Sites

Erasmus Medical Center, Rotterdam 2747891, Netherlands

Status

Recruiting

Address

Erasmus Medical Center

Rotterdam 2747891, , 3015 GE

Site Contact

Eline te Nijenhuis-Noort, MSc

[email protected]

+31-0107033055

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