Short-term effects of a eucaloric ketogenic diet in acromegaly patients
- Conditions
- Acromegaly10021112
- Registration Number
- NL-OMON46800
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
-Written informed consent male or female aged * 18.
-Documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor
-The patient is treated with lanreotide Autogel or octreotide long-acting release (LAR) on maximum doses for at least 6 months and has a serum IGF-I level above 120% of the age- and sex adjusted normal limits.
-Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow-up evaluation as specified in the protocol.
- Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
- It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study.
- Has a history of epilepsy
- Has been treated with any unlicensed drug within the last 30 days before study entry.
- Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subjects safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Diabetes type 1 or diabetes type 2 and using insulin
- Use of systemic corticosteroids within 60 days prior to screening
- Females of childbearing potential must be using contraception (we do not perform a pregnancy test), otherwise excluded from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the efficacy of two weeks eucaloric ketogenic diet on GH and IGF-I<br /><br>levels in acromegaly patients. The primary endpoints are the difference in GH<br /><br>and IGF-I levels before and after 2 weeks of ketogenic diet. </p><br>
- Secondary Outcome Measures
Name Time Method