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Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT03991897 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lymphedema is a debilitating disorder that severely impairs the quality of life of the patients and requires life-long attention. Treatment for lymphatic dysfunction remains largely symptomatic, without real cure. According to the International Society of Lymphology, lymphedema has to be treated with Decongestive Lymphatic Therapy. Research in the lab of Angiogenesis and Vascular Metabolism (PCA lab) reported in mice that metabolism of endothelial cells controls vessel sprouting. Experiments showed that a ketogenic diet (KD) reduced the edema of the mice tail and enhanced the lymphatic transport. Based on these proof-of-concept data, the investigators plan to test this innovative concept to ameliorate lymph vessel dysfunction in lymphedema patients. Randomisation will be performed between a ketogenic diet and an isocaloric diet with and without ketone ester supplementation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * \>18 years; * unilateral lymphedema of the arm lymph node dissection * lymphedema onset less than a year before the therapy starts * lymphedema defined as \>3% volume difference between both arms * lymphedema stage 1, stage 2a or stage 2b * absence of pregnancy at the time of enrollment and willingness to use adequate contraceptive measures until the end of the study; * oral and written approval of the informed consent presented at the time of the consultation by the physicians; * understanding Dutch Exclusion Criteria: * \<18 years; * edema of the limb with different etiology or later stage/onset as specified in the inclusion criteria; * presence of active cancer * pregnancy or active breastfeeding; * impossibility to participate for the entire study period; * mentally or physically unable to participate to the study; * presence of gastrointestinal intolerance or other serious illness (e.g. renal failure, hepatic dysfunction, heart failure, neurological impairment); * presence of diabetes or other metabolic disease; * contra-indication for the use of indocyanine green (ICG): allergy to ICG or iodine, hyperthyroidism.
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What it tests

  • Ketogenic diet
  • Isocaloric diet
  • Ketone ester supplementation
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Where

1 site
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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