Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema (Lipedema)
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- STATUS
- Recruiting
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- days left to enroll
- 33
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- participants needed
- 20
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- sponsor
- Washington University School of Medicine
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:
- Medical History & Physical Exam
- Urine Drug/Pregnancy Test
- Blood pressure, pulse, height, weight, shoulder and waist circumference measurements
- Electrocardiogram (ECG)
- Blood tests for routine lab analyses
- Oral Glucose Tolerance Test (OGTT)
- Screening Questionnaires
- Dual energy X-ray absorptiometry (DEXA)
- 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
- Metabolism study (hyperinsulinemic-euglycemic clamp procedure)
- Abdominal and Thigh Fat biopsies
- Immune function (performed in obese with lipedema subjects and BMI-matched controls).
Details
| Condition | Lipedema, Metabolism |
|---|---|
| Treatment | Weight Loss, Mediterranean diet |
| Clinical Study Identifier | NCT03271034 |
| Sponsor | Washington University School of Medicine |
| Last Modified on | 9 April 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
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