Localized adiposity Lipomatosis, not elsewhere classified
Conditions
Interventions
This longitudinal study is characterized as a double-blind randomized clinical trial in which neither the researchers nor the physicians know which implant contains the hormone or the placebo. Forty-t
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with a clinical diagnosis of menopause; women with a medical diagnosis of lipedema in any of the four grades (grade I, II, III or IV); residency in Belo Horizonte; signing of the informed consent form; commitment to following the proposed diet; participants must be willing to undergo necessary clinical or laboratory tests during the study, such as blood tests and body fat measurements; and have an active health insurance plan
Exclusion criteria
Exclusion criteria: Patients diagnosed with lymphedema; severe heart failure; renal or hepatic insufficiency; patients with androgen-dependent tumors (e.g., some types of breast cancer); genital bleeding of unknown origin; previous thrombotic event; patients with autoimmune disease; uncontrolled endocrine disorders such as type 1 or 2 diabetes; patients with ostial reflux of the great saphenous vein and/or small saphenous vein; reflux in the deep venous system (femoral vein and/or popliteal vein); psychiatric disorders such as schizophrenia and psychotic disorders; eating disorders such as anorexia nervosa and bulimia; patients who have undergone liposuction and/or surgery for lipedema in the last 6 months; patients with a history of severe adverse reactions to specific diets or who have conditions such as malabsorption syndrome; pregnant or breastfeeding women; women planning to become pregnant during the experimental period; Patients using medications that may directly interfere with the metabolism, treatment, or response to lipedema (e.g., weight-loss medications, steroids, or other hormonal therapies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The intervention is expected to promote the reduction of localized body fat in the regions typically affected by lipedema, in addition to contributing to the reduction of pain and edema associated with the pathology. Body fat will be assessed using densitometry with equipment that tracks whole-body fat, and perimeter measurements of the affected regions. Pain will be measured using a pressure algometer, and its perception will be quantified using two questionnaires: the Visual Analogue Scale (VAS) and the Brief Pain Inventory (BPI). Edema will be evaluated by clinical inspection and perimeter measurements, with standardized photographic documentation and comparative analysis over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements are expected in biochemical parameters that reflect: 1) a reduction in chronic inflammation, such as high-sensitivity CRP, homocysteine, insulin, TG/HDL ratio, CT/HDL ratio, ferritin; 2) hormonal modulation of estrogen and testosterone ;A slight increase in muscle mass is also expected, even in the absence of regular physical exercise, due to the androgenic action attributed to gestrinone;Improvement in patients' mental health and quality of life will be assessed through questionnaires;Possible side effects related to gestrinone use and dietary therapy will also be considered as secondary outcomes | — |
Countries
BR
Contacts
Public ContactLudmila;Giselle Lima;Foureaux
Universidade Federal de Minas Gerais;Universidade Federal de Minas Gerais
Outcome results
None listed