Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lipedema is a chronic fat tissue disorder that usually affects the lower limbs, excluding the feet. Clinical symptoms of lipedema include a noticeable disproportion between the upper and lower body, a tendency to easy bruising, and pain in the fatty tissue. It is a common disorder that occurs almost exclusively in women, potentially affecting around 11% of the adult population worldwide. The disease, especially in its advanced stages, has negative psychosocial consequences, leading to social isolation or depression, among other issues. The etiology of the disease is unknown, but genetic, hormonal, and inflammatory factors are likely involved in its pathogenesis. This disorder is characterized by the presence of low-grade inflammation in the fat tissue. The use of reduction diets combined with physical activity or bariatric surgery does not constitute an effective therapeutic approach for lipedema. Recent interventional studies show that an anti-inflammatory ketogenic diet leads to a reduction in leg volume and lipedema symptoms, including pain in the extremities.
This study aims to evaluate clinical, metabolic, inflammatory, and vascular characteristics in women with lipedema and to assess potential changes associated with dietary intervention - 7 months of ketogenic diet (low carbohydrate, high fat).
Participants undergo clinical, laboratory, and patient-reported outcome assessments to evaluate anthropometric parameters, quality of life, and selected biomarkers. The findings are expected to improve understanding of the biological mechanisms underlying lipedema and to support the development of targeted therapeutic strategies.
A total of 121 women were invited to participate in the study. The study group consisted of patients from the Angiology Outpatient Clinic at Wroclaw Medical University in Poland with the diagnosis of lipedema made by an angiologist (n=66). The control volunteer group was composed of women with overweight or obesity (body mass index, BMI= 25 kg/m2) who were not affected by lipedema (n=55).
All participants recruited to the study underwent following procedures at the beginning and at the end of the study:
Measurement of anthropometric parameters:
Questionnaires:
assessment of pain level in the leg - visual analogue scale (VAS)
assessment of psychological status, symptoms and quality of life:
assessment of food consuming - Food Frequency Questionnaire (FFQ)
Blood samples collection:
• collection of approximately 25 ml of peripheral blood for laboratory tests
Fat samples collection from the subcutaneous fatty tissue • collection of a drop subcutaneous fat from the thigh for metabolomic tests:
Of the original study population, 48 patients completed the study (28 in the lipedema group and 24 with overweight/obesity).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with lipedema (interventional group) | Experimental | Patients with diagnosis of lipedema who following the interventional (ketogenic) diet. |
|
| Patients with overweight/obesity (control group) | Experimental | Patients with overweight/obesity (BMI > 25 kg/m2) without lipedema symptoms who following the interventional (ketogenic) diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties | Behavioral | The interventional diet structure was similar to a typical ketogenic diet, with less than 50 g of carbohydrates per day. The diet was designed as a Mediterranean style with many food products with anti-inflammatory properties such as antioxidants, unsaturated fatty acids, herbs, spices, tea and coffee. The diet was reduced in saturated fatty acids and processed foods. All the involved participants received the personalized caloric-restricted low-carbohydrate high-fat (ketogenic) diet, based on the patient's preferences. The daily energy intake was divided into 3 meals, consisting of a source of protein, fat, and vegetable additives. They received individual 7-day meal plans to repeat for 7 months with recipes and a shopping list. The personalization of the dietary plans aimed to increase compliance with the diets. Additionally, each patient received detailed dietary recommendations that facilitated adherence to the dietary plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in leg circumferences | Changes in leg circumferences between 2 timepoints (baseline and end of study) | Up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change in body weight in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in body fat | Change in body fat percentage (%) measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical University | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
All data used to support the findings of this study are available from the corresponding author upon reasonable request due to the privacy of patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065134 | Lipedema |
| D050177 | Overweight |
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Experimental Arm Control Arm
Not provided
Not provided
Not provided
Not provided
|
| Up to 7 months |
| Change in lean body mass | Change in lean body mass in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in body water | Change in body water in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in visceral fat level | Change in visceral fat level measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study). Visceral fat level is measured on a scale from 1 (lowest level) to 20 (highest level). | Up to 7 months |
| Change in disability level | Change in disability level measured using the World Health Organization Disability Assessment Schedule II (WHO-DAS II) total score between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in depressive symptoms | Change in depressive symptoms measured using the Beck Depression Inventory-II (BDI-II) total score between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in anxiety and depression symptoms | Change in anxiety and depression symptoms measured using the Hospital Anxiety and Depression Scale (HADS) total score between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in lower extremity symptoms | Change in lower extremity symptoms measured using the Lymphedema Quality of Life Questionnaire (LYMQOL) total score between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in psychological distress | Change in psychological distress measured using the General Health Questionnaire (GHQ-28) total score between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in quality of life | Change in quality of life measured using the Short Form Health Survey (SF-36) total score between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in pain intensity in the legs | Change in pain intensity assessed using the Visual Analogue Scale (VAS) between 2 timepoints (baseline and end of study). Pain intensity is measured using the VAS, a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. | Up to 7 months |
| Change in leptin concentration | Change in serum leptin concentration [ng/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in adiponectin concentration | Change in serum adiponectin concentration [ng/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in resistin concentration | Change in serum resistin concentration [pg/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in vaspin concentration | Change in serum vaspin concentration [pg/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in visfatin concentration | Change in serum visfatin concentration [ng/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in TNF-α concentration | Change in serum tumor necrosis factor-alpha (TNF-α) concentration measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in IL-1β concentration | Change in serum interleukin-1 beta (IL-1β) concentration measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in IL-8 concentration | Change in serum interleukin-8 (IL-8) concentration measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in IL-10 concentration | Change in serum interleukin-10 (IL-10) concentration measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in IL-13 concentration | Change in serum interleukin-13 (IL-13) concentration measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in CRP concentration | Change in serum C-reactive protein (CRP) concentration measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in TBARS concentration | Change in serum thiobarbituric acid reactive substances (TBARS) concentration [µmol/l] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in 8-iso-prostaglandin F2α concentration | Change in serum 8-iso-prostaglandin F2α concentration [pg/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in protein carbonyl content | Change in serum protein carbonyl content [nmol/mg protein] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in total antioxidant capacity | Change in serum total antioxidant capacity (TAC) [mmol Trolox eqiv./l] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in SOD activity | Change in serum superoxide dismutase (SOD) [U/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in CAT activity | Change in serum catalase (CAT) [U/ml] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in vitamin C concentration | Change in serum vitamin C concentration [µmol/l] measured between 2 timepoints (baseline and end of study). | Up to months |
| Change in vitamin A concentration | Change in serum vitamin A concentration [µmol/l] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in vitamin E concentration | Change in serum vitamin E concentration [µmol/l] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in VEGF-A concentration | Change in serum and subcutaneous tissue VEGF-A concentration [pg/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in VEGF-C concentration | Change in serum and subcutaneous tissue VEGF-C concentration [pg/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in VEGF-D concentration | Change in serum and subcutaneous tissue VEGF-D concentration [pg/mL] measured between 2 timepoints (baseline and end of study). | Up to months |
| Change in angiopoietin-2 concentration | Change in serum and subcutaneous tissue angiopoietin-2 concentration [pg/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in sICAM-1 concentration | Change in serum and subcutaneous tissue soluble ICAM-1 (sICAM-1) concentration [ng/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in sVCAM-1 concentration | Change in serum and subcutaneous tissue soluble VCAM-1 (sVCAM-1) concentration [ng/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in P-selectin concentration | Change in serum and subcutaneous tissue p-selectin concentration [pg/mL] measured between 2 timepoints (baseline and end of study). | Up to 7 months |
| Change in eicosanoids concentrations | Change in serum/plasma concentrations of selected eicosanoids measured between 2 timepoints (baseline and end of study) using targeted metabolomics (ng/mL):
| Up to 7 months |
| Change in endocannabinoids concentrations | Change in serum/plasma concentrations of selected endocannabinoids concentrations measured between 2 timepoints (baseline and end of study) using targeted metabolomics (ng/mL):
| Up to 7 months |
| Change in nitric oxide metabolites concentrations | Change in serum/plasma concentrations of selected nitric oxide metabolites concentrations measured between 2 timepoints (baseline and end of study) using targeted metabolomics (µmol/L):
| Up to 7 months |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |