NCT03991897 Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
| NCT ID | NCT03991897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 81 participants in total. It began in 2025-10-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Nicolas Timmermans, Msc
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT03991897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03991897 currently recruiting?
Yes, NCT03991897 is actively recruiting participants. Contact the research team at sarah.thomis@uzleuven.be for enrollment information.
Where is the NCT03991897 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT03991897 clinical trial?
NCT03991897 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Nicolas Timmermans, Msc at KU Leuven. The trial plans to enroll 81 participants.