KETOgenic Diet Therapy in Patients With ACROmegaly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Ketogenic diet
Dietary supplementA 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 supplementThe control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: People with acromegaly following Ketogenic dietExperimental treatment 1 intervention
Group B: People with acromegaly following Mediterranean dietActive comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline, 3 months and 6 months.Other outcomes
1
Food intake
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).
Time frame
At baseline, 3 months and 6 months.2
Quality of Life questionnaire
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.
Time frame
At baseline, 3 months and 6 months.3
Quality of Life questionnaire
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 )).
Time frame
At baseline, 3 months and 6 months.4
Qualtity of Life questionnaire
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.
Time frame
At baseline, 3 months and 6 months.Sponsors and contacts
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Source ClinicalTrials.gov