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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with acromegaly following Ketogenic diet | Experimental | 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 | Active Comparator | The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, 3 months and 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | At baseline, 3 months and 6 months. |
| Quality of Life questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten A. Berk, Dr. | Contact | +31 0107033055 | k.berk@erasmusmc.nl | |
| Eline te Nijenhuis-Noort, MSc | Contact | +31 0107033055 | l.tenijenhuis-noort@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | 3015 GE | Netherlands |
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| ID | Term |
|---|---|
| D049912 | Growth Hormone-Secreting Pituitary Adenoma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Mediterranean diet | Dietary Supplement | The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet. |
|
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 | 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 | 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 | GH level in ug/l | At baseline, 3 months and 6 months. |
| Serum parameters | IGF1 level in nmol/l | At baseline, 3 months and 6 months. |
| Serum Parameters | Fasting plasma glucose in mmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | Fasting insulin in pmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | HbA1c in mmol/mol | At baseline, 3 months and 6 months. |
| Serum parameters | Total cholesterol in mmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | HDL-cholesterol in mmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | LDL-cholesterol in mmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | Triglycerides in mmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | Free fatty acids in mmol/l | At baseline, 3 months and 6 months. |
| Serum parameters | β-Hydroxybutyrate in mmol/l | At baseline, 3 months and 6 months. |
| Anthropometry | Height in m | At baseline, 3 months and 6 months. |
| Anthropometry | Weigth in kg | At baseline, 3 months and 6 months. |
| Anthropometry | BMI in kg/m2 | At baseline, 3 months and 6 months. |
| Anthropometry | Fat mass in kg and in percent | At baseline, 3 months and 6 months. |
| Anthropometry | Fat free mass (skeletal muscle mass) in kg | At baseline, 3 months and 6 months. |
| Anthropometry | Body water in percent | At baseline, 3 months and 6 months. |
| Anthropometry | Hand grip strength in kg | At baseline, 3 months and 6 months. |
| Anthropometry | Resting energy expenditure in kcal/day. | At baseline, 3 months and 6 months. |
| D010911 |
| Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000095500 | Diet, Plant-Based |