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New treatment option for Acromegaly Due to Pituitary Adenoma
Official title KETOgenic Diet Therapy in Patients With ACROmegaly
ClinicalTrials.gov ID: NCT06949891
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, 18 years or older
- Diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor
- IGF-I levels above 80% upper limit of the normal range (xULN)) on a stable medication dose for at least 4 months
- Written informed consent
You likely can't join if
- Pregnancy or breastfeeding
- Pegvisomant treatment
- Has undergone pituitary surgery or radiotherapy within 6 months prior to s study entry;
- It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study;
- History or presence of epilepsy;
- Participation in a trail of an experimental drug or device within 30 days prior to screening;
See the full eligibility criteria
- Male or female, 18 years or older
- Diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor
- IGF-I levels above 80% upper limit of the normal range (xULN)) on a stable medication dose for at least 4 months
- Written informed consent
- Pregnancy or breastfeeding
- Pegvisomant treatment
- Has undergone pituitary surgery or radiotherapy within 6 months prior to s study entry;
- It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study;
- History or presence of epilepsy;
- Participation in a trail of an experimental drug or device within 30 days prior to screening;
- Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Screening HbA1c \> 6,5%;
- Use of antidiabetic medication other than Metformin
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.