Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema (Lipedema)

  • STATUS
    Recruiting
  • End date
    Mar 9, 2023
  • participants needed
    20
  • sponsor
    Washington University School of Medicine
Updated on 9 April 2022
Accepts healthy volunteers

Summary

Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain and accumulation of fluid. Little is known about the functional changes that lead to fat accumulation and pain in women with lipedema. The goals of this project are to conduct a comprehensive characterization of abdominal and femoral fat tissues in lean and obese women with lipedema and to evaluate the potential effect of diet-induced weight loss as a therapy.

Once enrolled in the study, the following tests will be conducted on lean women with lipedema: characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin) and adipose tissue biology. The following tests will be conducted on obese women with lipedema: characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin), adipose tissue biology, and immune system function/inflammation. As control, we will have BMI-matched women that are metabolically normal lean (MNL), metabolically normal obese (MNO) and metabolically abnormal obese (MAO) already analyzed in different studies at Washington University (IRB 201512086). MNL, MAO and MNO subjects underwent the same testing described above for the lipedema. Therefore, we will use the data generated from IRB 201512086 as comparison groups in the statistical analysis to understand differences and similarities between lipedema and obesity.

A second aim of the study is to determine the effect of diet-induced weight loss on body composition, insulin sensitivity, and adipose tissue biology in women with lipedema. The results from this second aim of the study will hopefully provide important insights on the efficacy of diet therapy in managing lipedema.

Description

Once informed consent has been obtained, participants will complete 1 screening visit.

The screening visit includes a medical history, physical examination, pregnancy test (for women of childbearing potential), blood tests, urine drug test, an oral glucose tolerance test, resting electrocardiogram (ECG), and questionnaires.

Baseline testing will be performed in 2 visits requiring 1 inpatient overnight stay and will require ~30h to complete testing. Testing will include imaging scans to determine leg muscle mass; abdominal (belly) fat mass and liver fat content; DXA scan; blood samples; hyperinsulinemic-euglycemic clamp procedure; immune system function/inflammation (performed exclusively in obese with lipedema subjects and BMI-matched controls); and adipose tissue biopsies.

Once Baseline Testing is completed, participants will start 8-10% dietitian and/or behaviorist guided weight-loss for about 4 to 6 months.

Participant will keep a food diary and have weekly visits (in person or remote) with a study dietitian and/or behaviorist.

After weight loss, the testing completed during baseline will be repeated.

Study procedures:

  1. Medical History & Physical Exam
  2. Urine Drug/Pregnancy Test
  3. Blood pressure, pulse, height, weight, shoulder and waist circumference measurements
  4. Electrocardiogram (ECG)
  5. Blood tests for routine lab analyses
  6. Oral Glucose Tolerance Test (OGTT)
  7. Screening Questionnaires
  8. Dual energy X-ray absorptiometry (DEXA)
  9. Magnetic Resonance Imaging (MRI) for Body Composition to determine (a) the amount of fat in the liver, abdomen (belly), and lower leg; and (b) how much muscle mass is in the thigh
  10. Metabolism study (hyperinsulinemic-euglycemic clamp procedure)
  11. Abdominal and Thigh Fat biopsies
  12. Immune function (performed in obese with lipedema subjects and BMI-matched controls).

Details
Condition Lipedema, Metabolism
Treatment Weight Loss, Mediterranean diet
Clinical Study IdentifierNCT03271034
SponsorWashington University School of Medicine
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Lipedema
lean women with lipedema (BMI >19.5 kg/m² and <26.0 kg/m²)
women with obesity and lipedema (BMI >30.0 kg/m² and <50.0 kg/m²)

Exclusion Criteria

Medical, surgical or biological menopause
Previous bariatric surgery
Diagnosis of Type 2 Diabetes
HbA1C <5.7%
Structured exercise >2 days/week for ≥35 minutes of intense exercise (e.g., jogging, activity that cause heavy breathing and sweating) or ≥150 minutes per week of structured exercise (e.g., brisk walking)
Unstable weight (>4% change in weight during the last 2 months before entering the study)
Significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or cardiovascular disease)
Cancer or cancer that has been in remission for <5 years
Polycystic Ovary Syndrome
Major psychiatric illness
Conditions that render participant unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
Use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study
Smoke cigarettes >10 cigarettes/week
Consume >14 units of alcohol per week
Pregnant or lactating women
Persons who are not able to grant voluntary informed consent
Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note