LipoedemaNCT01759004
Physical Condition in Lipedema and Obesity
A study testing volume, muscle strength, physical condition, BMI in people with Lipoedema and Obesity, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- volume, muscle strength, physical condition, BMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- BMI ≥ 30
- women
- age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Drachten, Provincie Friesland, 9202 NN
About this study
Official title: Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study
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.
Read the 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.
- Being tested
- volume, muscle strength, physical condition, BMI
- Keywords
- lipoedema, obesity
- Medical subject headings
- Lipedema, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume, muscle strength, physical condition, BMIOther
phys. condition, muscle strength, volumetry, BMI
| Study group | Role | What they receive |
|---|---|---|
| patient with lipoedema | Active comparator | Lipedema group:
* diagnosed with lipedema following the criteria of Wold
* women
* age ≥ 18 years
clinimetrics: volume, muscle strength, physical condition, BMI Receives: Other: volume, muscle strength, physical condition, BMI |
| patients with obesity | Active comparator | Obesity group:
* BMI ≥ 30
* women
* age ≥ 18 years
clinimetrics: volume, muscle strength, physical condition, BMI Receives: Other: volume, muscle strength, physical condition, BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: June 2013
Secondary outcomes (1)
walking capacity
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
Measured: June 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipoedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nij Smellinghe Hosptial
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Damstra, Nij Smellinghe Hosptial
- Investigators
- RJ Damstra, MD PhD, Principal investigator, Nij Smellinghe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759004
- Sponsor's protocol ID
- NS4NL
- Other IDs
- Nij Smellinghe hospital
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2012
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study
- ClinicalTrials.gov ID
- NCT01759004
- Acronym / sponsor ID
- NS4NL
- Keywords
- lipoedema, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nij Smellinghe HosptialUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with lipoedema | Active comparator | Other: volume, muscle strength, physical condition, BMILipedema group: * diagnosed with lipedema following the criteria of Wold * women * age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI |
| patients with obesity | Active comparator | Other: volume, muscle strength, physical condition, BMIObesity group: * BMI ≥ 30 * women * age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- diagnosed with lipedema following the criteria of Wold et al3
- women
- age ≥ 18 years
- BMI ≥ 30
Key exclusion criteria (5 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- none
- an obesity intervention with physical training in the ≤12 months prior to the measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volume, muscle strength, physical condition, BMIphys. condition, muscle strength, volumetry, BMI | Other | patient with lipoedema, patients with obesity |
Primary outcome
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).
1 secondary outcome
walking capacity
Time frame: June 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- General website form the Nij Smellinghe hospitalLink provided by the sponsor.
- The foundation related to the expert centre organizing researchLink provided by the sponsor.
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Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RJ Damstra, MD PhD principal investigator
Nij Smellinghe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing volume, muscle strength, physical condition, BMI in people with Lipoedema and Obesity, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: June 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2013.