Acromegaly Due to Pituitary Adenoma, Ketogenic Diet, Mediterranean Diet
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetogenic 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_SUPPLEMENTMediterranean diet
The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life questionnaire | 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. |
| Qualtity of Life questionnaire | 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. |
| Food intake | 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). |
| Serum Parameters | At baseline, 3 months and 6 months. | Fasting plasma glucose in mmol/l |
| Anthropometry | At baseline, 3 months and 6 months. | Height in m |
| Serum parameters | At baseline, 3 months and 6 months. | GH level in ug/l |
Countries
Netherlands
Contacts
Primary ContactKirsten A. Berk, Dr.
Backup ContactEline te Nijenhuis-Noort, MSc
Outcome results
None listed