Clinical trial NCT01759004: Physical Condition in Lipedema and Obesity
Official title: Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipoedema
Obesity
Keywords: lipoedema
obesity
Lead sponsor: Nij Smellinghe Hosptial
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of lipoedema and obesity are often mixed up, unclear stated and often there is a misdiagnosis. The primary aim is to investigate whether there is a difference in muscle strength between women with lipedema and women with obesity. The secondary aim is to investigate whether there is a difference in physical fitness between women with lipedema and women with obesity.

Detailed description: Lipedema is a genetically mediated disorder of adipose tissue that occurs exclusively in women. Lipedema is an under-recognized condition, often misdiagnosed as lymfedema or dismissed as simple obesity. The diagnosis of lipedema is a clinical diagnosis and may be challenging to determine among patients who are obese. Measurements of muscle strength and physical fitness may give more clarity to differentiate between lipedema and obesity. This may lead to improvements in the criteria of diagnosing lipedema. The research question of the study is: Is there a difference in muscle strength between adult women with lipedema and adult women with obesity?

In this study 40 patients will be studied; 20 patients in every group. Besides the general data as length, weight, age, abdominal circumference, volume of the legs additional muscle strength and physical fitness of women with lipedema and women with obesity will be measured and analysis.

This study doesn't involve a negligible risk for participants. The study will not have direct benefit for the participants, but may be useful in giving more clarity in defining the phenotype for patients with lipedema.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Lipedema group:

* diagnosed with lipedema following the criteria of Wold et al3
* women
* age ≥ 18 years

Obesity group:

* BMI ≥ 30
* women
* age ≥ 18 years

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Lipedema group:

- none

Obesity group:

- an obesity intervention with physical training in the ≤12 months prior to the measurement

Primary outcomes:
measure: The main determinant of this study is a muscle strength test of the Quadriceps muscle of the left and right leg measured with the MircoFET.
timeFrame: June 2013
Secondary outcomes:
measure: walking capacity
timeFrame: June 2013
Other outcomes:
Locations:
city: Drachten
country: Netherlands
facility: Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
state: Friesland
Study officials:
affiliation: Nij Smellinghe Hospital
name: RJ Damstra, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: