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Physical Condition in Lipedema and Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01759004
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Lipoedema Obesity Other: volume, muscle strength, physical condition, BMI

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study
Study Start Date : December 2012
Primary Completion Date : June 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: patient with lipoedema

Lipedema group:

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

clinimetrics: volume, muscle strength, physical condition, BMI

Other: volume, muscle strength, physical condition, BMI
phys. condition, muscle strength, volumetry, BMI
Active Comparator: patients with obesity

Obesity group:

  • BMI ≥ 30
  • women
  • age ≥ 18 years

clinimetrics: volume, muscle strength, physical condition, BMI

Other: volume, muscle strength, physical condition, BMI
phys. condition, muscle strength, volumetry, BMI


Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: June 2013 ]
    Muscle strength will be measured with the MicroFET. This test is performed when de patient is sitting. The patient is instructed to perform knee extension three times for each leg. The test result is de average score of each leg. The MicroFET has been shown to be a valid measurement with the break-method.14,15 Schaubert et al.15 and Bohannon et al.14 looked at the reliability of MicroFET measurements and found a good Intraclass Correlation Coefficient (ICC) values of 0.807-0.97115 and ICC>.097014 respectively. The test procedure of the break-method is described in Appendix 1).


Secondary Outcome Measures :
  1. walking capacity [ Time Frame: June 2013 ]
    After performing the muscle strength test, the participants will be asked to perform a test for physical fitness, knowing the Six Minute Walk Test (6MWT). Walking capacity will be measured with the 6MWT. This standardized test is performed on a 30 meters course where every five meter is marked. The patient will be instructed to cross a maximum distance in six minutes with a possibility to stop or rest if necessary.16 The result is the walking distance in meters (m) after six minutes (with five meter exactness). The 6MWT is a good test for functional activity. De walking distance performed with the 6MWT gives a good sight in the amount of activities in daily living (ADL) of the performer.17 Rjeski et al.17 found a good validity and correlation with the VO2max (r=0.64) for participants with chronic obstructive pulmonary disease (COPD). The test-retest reliability of this test is good (ICC 0.94).18


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759004


Locations
Netherlands
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Drachten, Friesland, Netherlands, 9202 NN
Sponsors and Collaborators
Nij Smellinghe Hosptial
Investigators
Principal Investigator: RJ Damstra, MD PhD Nij Smellinghe Hospital
More Information

Additional Information:
Responsible Party: R.J. Damstra, Dermatologist MD PhD, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier: NCT01759004     History of Changes
Other Study ID Numbers: NS4NL
Nij Smellinghe hospital ( Other Identifier: Nij Smellinghe hospital )
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by R.J. Damstra, Nij Smellinghe Hosptial:
lipoedema
obesity

Additional relevant MeSH terms:
Obesity
Lipedema
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Connective Tissue Diseases