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

J.L.C.M. van Saase, MD, PhDHead of the department of Internal MedicineErasmus University Medical Centerj.vansaase@erasmusmc.nl0 sites10 target enrollmentTBD

Conditions- Patients with active acromegaly (IGF-I levels above 120% ULN)- Ziekte acromegalie

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: - Patients with active acromegaly (IGF-I levels above 120% ULN)- Ziekte acromegalie
Sponsor: J.L.C.M. van Saase, MD, PhDHead of the department of Internal MedicineErasmus University Medical Centerj.vansaase@erasmusmc.nl
Enrollment: 10
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

J.L.C.M. van Saase, MD, PhDHead of the department of Internal MedicineErasmus University Medical Centerj.vansaase@erasmusmc.nl

Eligibility Criteria

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