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Physical Condition in Lipedema and Obesity

NCT ID: NCT01759004

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Lipoedema Obesity

Keywords

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lipoedema obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patient with lipoedema

Lipedema group:

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

clinimetrics: volume, muscle strength, physical condition, BMI

Group Type ACTIVE_COMPARATOR

volume, muscle strength, physical condition, BMI

Intervention Type OTHER

phys. condition, muscle strength, volumetry, BMI

patients with obesity

Obesity group:

* BMI ≥ 30
* women
* age ≥ 18 years

clinimetrics: volume, muscle strength, physical condition, BMI

Group Type ACTIVE_COMPARATOR

volume, muscle strength, physical condition, BMI

Intervention Type OTHER

phys. condition, muscle strength, volumetry, BMI

Interventions

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volume, muscle strength, physical condition, BMI

phys. condition, muscle strength, volumetry, BMI

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nij Smellinghe Hosptial

OTHER

Sponsor Role lead

Responsible Party

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R.J. Damstra

Dermatologist MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RJ Damstra, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nij Smellinghe Hospital

Locations

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Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Drachten, Provincie Friesland, Netherlands

Site Status

Countries

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Netherlands

Related Links

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http://www.nijsmellinghe.nl

General website form the Nij Smellinghe hospital

http://www.slcn.nl

The foundation related to the expert centre organizing research

Other Identifiers

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Nij Smellinghe hospital

Identifier Type: OTHER

Identifier Source: secondary_id

NS4NL

Identifier Type: -

Identifier Source: org_study_id