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

Metabolism Clinical Trial

Official title: Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 approximately 30 hours in total to complete testing. Testing will include imaging scans to determine thigh fat mass; abdominal (belly) fat mass and liver fat content; DXA scan to assess whole-body and leg fat mass; blood samples; hyperinsulinemic-euglycemic clamp procedure; immune system function/inflammation (performed exclusively in people with obesity and lipedema and BMI-matched controls); and adipose tissue (fat) biopsies.

Once Baseline Testing is completed, participants will start 5-10% 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

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 (DXA) scan to assess whole-body and leg fat mass

9. Magnetic Resonance Imaging (MRI) for Body Composition to determine the amount of fat in the liver, abdomen (belly), and thigh.

10. Metabolism study (hyperinsulinemic-euglycemic clamp procedure) to assess how well insulin works to control blood glucose (sugar) concentrations.

11. Abdominal (belly) and thigh fat biopsies

12. Immune function (performed in obese with lipedema subjects and BMI-matched controls). ;

Related Conditions & MeSH terms

• Lipedema
• Metabolism
• Weight Loss

• NCT number: NCT03271034
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2017
• Completion date: December 2024