Short-term effects of a eucaloric ketogenic diet in acromegaly patients - Ketogenic diet in acromegaly

Academisch Medisch Centrum0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•-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

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