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Completed NCT04632810

Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema

Conditions: Lipedema

Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Helse Nord-Trøndelag HF

Location: Levanger Hospital, Nord-Trøndelag Hospital Trust Levanger

Summary

Lipedema is a female progressive fat disorder, characterized by a symmetrical increase in subcutaneous adipose tissue in the lower extremities with the exception of the waist. The condition is often misdiagnosed and underdiagnosed. The etiology is poorly understood. Affects about 11% of all women and may lead to pain and immobility. The pathophysiology may be related to sex hormones and inflammatory response. Lipedema fat has been reported not to respond to lifestyle changes or bariatric surgery, both in terms of weight loss and symptom reduction; including pain and quality of life. Clinical research on the effect of dietary interventions on lipedema does not exist, but a pilot study with a ketogenic diet showed a significant reduction in pain regardless of weight loss. The aim of the research project will be to investigate whether a ketogenic diet can be a treatment option for patients with lipedema. Therefore, a randomized controlled trial will be conducted to compare the effects of two diets. 1) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet for 8 weeks. Pain and quality of life will be mesured at start and immediately after the intervention. The hypothesis is that a ketogenic diet may reduce pain and improve quality of life.

Eligibility Criteria

Inclusion Criteria: * Diagnosed with lipedema by skilled physical therapists * Body mass index \> 30kg/m2 and \< 45kg/m2 * Stable weight over the last three months (+2-3kg) * Not currently dieting to lose weight * Willing to meet for follow-ups every second week during the intervention * Willing to sign an informed consent before entering the study Exclusion Criteria: * Pregnant or breast feeding * History of infectious diseases * Medication known to affect obesity * Enrolled in any other obesity treatment * Having had bariatric surgery. * Kidney disease is excluded * History of psychological disorders * Not mastering a Scandinavian language * Being mentally disabled * Malign disease * Diabetes * Any disease that leads to dietary advice that is not consistent with intervention advice

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04632810). StuddyBuddy aggregates publicly available trial information.