Kortetermijneffect van een eucalorisch ketogeen dieet op de ziekte acromegalie

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria : Male or female subject of 18 years or older; „h Documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor; 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; Signed informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study: „h Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry; „h It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study; „h History or presence of epilepsy; „h Participation in a trail of an experimental drug or device within 30 days prior to screening; „h 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; „h 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; „h Diabetes type 1 or diabetes type 2 and using insulin „h 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
To assess the efficacy of two weeks eucaloric ketogenic diet on GH and IGF-I levels in acromegaly patients. The primary endpoints are the difference in GH and IGF-I levels before and after 2 weeks of ketogenic diet.

Secondary Outcome Measures

Name	Time	Method
The secondary objective of the study is to evaluate safety and the effect of a eucaloric ketogenic diet on: „h blood glucose levels; „h insulin secretion; „h body weight; „h lipid profile, especially on triglycerides and free fatty acids