Ketogenic diet therapy for patients with acromegaly

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a ketogenic diet compared to a Mediterranean diet in patients diagnosed with acromegaly due to a pituitary adenoma. Acromegaly is characterized by excessive growth hormone production, leading to various health complications. The trial aims to assess whether dietary interventions can help normalize growth hormone and IGF-1 levels, potentially improving patient outcomes. Participants will be monitored for changes in metabolic parameters and overall quality of life.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Kirsten A. Berk, Dr.
• Email: k.berk@erasmusmc.nl
• Phone: +31 0107033055

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Managing pasireotide-related high blood sugar in acromegaly with a ketogenic diet

  This study tests whether a very-low carbohydrate ketogenic diet can help lower HbA1c and fasting glucose in adults with acromegaly who develop high blood sugar while taking pasireotide.

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• Diet patterns and gut health: effects of ketogenic, vegetarian, and habitual diets

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• Ketogenic Diet and Alcohol Intoxication: Can ketosis affect brain function and alcohol response

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  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT07602270

• Pasireotide LAR and bone health in adults with acromegaly

  This study will test whether switching adults with uncontrolled acromegaly to pasireotide LAR changes bone turnover and the risk of vertebral fractures.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, RM · NCT07179926

• Identifying genetic factors that predict dietary intervention success in IBS

  This study is trying to find out if certain genes can help predict how well people with Irritable Bowel Syndrome will respond to a special diet that combines low FODMAP and Mediterranean foods.

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• Using a mobile app to help university students follow the Mediterranean diet

  This study tests if a mobile app can help university students stick to the Mediterranean diet better than those who don’t use the app.

  Recruiting University of Seville · Seville · NCT05532137

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.