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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271034
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Lipedema Metabolism Dietary Supplement: Weight loss Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baseline Lipedema characterization
Body composition and Fat distribution, adipose tissue biology, metabolic and immune function in women with Lipedema. Participants will receive a low-calorie diet therapy in the form of low calorie meals or shakes.
Dietary Supplement: Weight loss
Participants will lose weight by utilizing a low caloric diet and meeting with a study dietitian and/or behaviorist weekly for ~4 months.




Primary Outcome Measures :
  1. Body Composition and Fat distribution [ Time Frame: 6 months ]
    total body, upper and lower body fat masses, ii) intra-abdominal fat, and iii) intrahepatic triglyceride content

  2. Metabolic function insulin sensitivity [ Time Frame: 7 months ]
    multi-organ (liver, skeletal muscle and adipose tissue) insulin sensitivity

  3. Metabolic function [ Time Frame: 6 months ]
    β-cell function.

  4. Immune system function (obese women with lipedema and BMI-matched controls) [ Time Frame: 6 months ]
    upper and lower body subcutaneous adipose tissue stromal vascular fraction content of immune cells; and ii) upper and lower body subcutaneous adipose tissue gene expression of markers of inflammation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03271034


Contacts
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Contact: Janet Winkelmann 314-402-7119 janetwinkelmann@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Janet Winkelmann         
Principal Investigator: Samuel Klein, MD         
Sub-Investigator: Vincenza Cifarelli, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Samuel Klein, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03271034    
Other Study ID Numbers: 201702107
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Lipedema
Metabolism
Body Composition
Fat Distribution
Immunology
Additional relevant MeSH terms:
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Lipedema
Weight Loss
Body Weight Changes
Body Weight
Connective Tissue Diseases