E88.2
Conditions
Interventions
Group 1: Lipoedema patients
From the age of 18
n=40
Examinations:
General questionnaires:
- Health status via SF-36
- Canadian Consensus Criteria questionnaire
- Mental stress via PHQ-9
- Physical
(11 items on fatigue)
- PEM criteria
(11 items on symptoms and their severity)
- COMPASS-31
(31 items on autonomic manifestations, scales: orthostatic, vasomotor, secretomotor, gastrointestinal, bladder, pupillomotor)
Laboratory analyses of blood samples:
- Level of functional AAB against G
Sponsors
Klinik für Plastische Chirurgie, UKM/Fachklinik Hornheide,
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adult women with and without lipoedema - No ME/CFS diagnosis required in advance - Lipoedema stages 1-3 - Untreated and non-surgically treated lipoedema - Age between 18 and 65 - only persons capable of giving consent
Exclusion criteria
Exclusion criteria: - Lipometabolic disorders (other than lipoedema) - Post liposuction - Cardiac pacemaker or defibrillator - Cardiac diseases (myocardial infarction <6 months, severe CHD, sre CHD, severe hypertension, severe heart failure) - haematomas, injuries or skin diseases in the area of the examination sites - Connective tissue diseases / infections - epilepsy - Post-traumatic stress disorder - Psychotic disorders, substance dependence, severe affective disorders with impaired judgement - Pregnant and breastfeeding women - Underweight - minors - Patients unable to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Symptoms of ME/CFS In this study, we plan to (1) use anamnestic data symptoms, disease progression, secondary diagnoses, medication use, especially hormone preparations) and specific questionnaires, compare the symptoms of ME/CFS in lipedema patients to a control group; (2) measure functional AAB against specific G-protein-coupled receptors (GPCR) associated with ME/CFS and hormone levels based on a blood sample; and (3) a pulse wave analysis measurement of changes in vasoregulation (e.g., arterial stiffness) to be collected: General questionnaires: - Health status via SF-36 - Canadian Consensus Criteria questionnaire - Mental stress via PHQ-9 - Physical activity via LTEQ Symptom-specific questionnaires - Bell Score limitation due to ME/CFS, (10 levels from 0 (severe) to 100 points (none)) - Chalder Fatigue Scale; (11 items on fatigue) - PEM criteria; (11 items on symptoms and their severity) - COMPASS-31; (31 items on autonomic manifestations, scales: orthostatic, vasomotor, secretomotor, gastrointestinal, bladder, pupillomotor) Laboratory analyses of blood samples: - Level of functional AAB against GPCR, i.e., 1-AdR-AAB, 2-AdR AAB, 1-AdR-AAB, 2-AdR-AAB, M1- to M5-AchR-AAB, TSHDS-IgM-AAB, FGF receptor 3-AAB Laboratory analysis of urine sample: - Determination of cycle day Examination procedures: - Pulse wave analysis (SomnoTouch, SomnoMedics, CE mark 0297) - Orthostatic test, here also all measurement procedures via SomnoTouch, see above: NASA Lean Test: | — |
Secondary
| Measure | Time frame |
|---|---|
| - Level of functional AAB against GPCR (detail see study procedure) - Arterial stiffness - Orthostatic circulatory response (orthostatis dysregulation, postural tachycardia syndrome, heart rate variability) - Mental stress - Physical activity - Hormonal changes - Comorbidities such as obesity, endometriosis Hypothyroidism, depression, Mast cell activation syndrome - Function of the microcirculation | — |
Countries
Germany
Contacts
Public ContactLena Busch
Universitätsklinikum Münster
Outcome results
None listed