Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema (Lipedema)
Primary Purpose
Lipedema, Metabolism
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss
Sponsored by
About this trial
This is an interventional treatment trial for Lipedema focused on measuring Lipedema, Metabolism, Body Composition, Fat Distribution, Immunology
Eligibility 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.
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Baseline Lipedema characterization
Arm Description
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.
Outcomes
Primary Outcome Measures
Body Composition and Fat distribution
total body, upper and lower body fat masses, ii) intra-abdominal fat, and iii) intrahepatic triglyceride content
Metabolic function insulin sensitivity
multi-organ (liver, skeletal muscle and adipose tissue) insulin sensitivity
Metabolic function
β-cell function.
Immune system function (obese women with lipedema and BMI-matched controls)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03271034
First Posted
August 29, 2017
Last Updated
September 19, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03271034
Brief Title
Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
Acronym
Lipedema
Official Title
Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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:
Medical history & physical exam
Urine drug/pregnancy Test
Blood pressure, pulse, height, weight
Electrocardiogram (ECG)
Blood tests for routine lab analyses
Oral glucose tolerance test (OGTT)
Screening Questionnaires
Dual energy X-ray absorptiometry (DXA) scan to assess whole-body and leg fat mass
Magnetic Resonance Imaging (MRI) for Body Composition to determine the amount of fat in the liver, abdomen (belly), and thigh.
Metabolism study (hyperinsulinemic-euglycemic clamp procedure) to assess how well insulin works to control blood glucose (sugar) concentrations.
Abdominal (belly) and thigh fat biopsies
Immune function (performed in obese with lipedema subjects and BMI-matched controls).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema, Metabolism
Keywords
Lipedema, Metabolism, Body Composition, Fat Distribution, Immunology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baseline Lipedema characterization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Weight loss
Intervention Description
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 Measure Information:
Title
Body Composition and Fat distribution
Description
total body, upper and lower body fat masses, ii) intra-abdominal fat, and iii) intrahepatic triglyceride content
Time Frame
6 months
Title
Metabolic function insulin sensitivity
Description
multi-organ (liver, skeletal muscle and adipose tissue) insulin sensitivity
Time Frame
7 months
Title
Metabolic function
Description
β-cell function.
Time Frame
6 months
Title
Immune system function (obese women with lipedema and BMI-matched controls)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikki Plassmeyer, MA, RDN, LD
Phone
314-362-0590
Email
nikkip@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikki Plassmeyer, MA, RDN, LD
Phone
314-362-0590
Email
nikkip@wustl.edu
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
First Name & Middle Initial & Last Name & Degree
Vincenza Cifarelli, PhD
12. IPD Sharing Statement
Learn more about this trial
Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
We'll reach out to this number within 24 hrs