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

NCT03271034 | Completed DMC

• 1 other identifier: 201702107
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 groups, we will compare body composition and insulin sensitivity to: i) women with obesity without lipedema who are matched on age, body mass index, total body fat mass, and percent body weight as fat; and ii) women who were lean and healthy to serve as a normal comparator for the 2 groups with obesity. Participants in the 2 control groups will enroll in a different study at Washington University (IRB# 201512086) where the same procedures will be performed to assess body composition and insulin sensitivity. 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 provide important insights on the efficacy of diet therapy in managing lipedema.

Conditions

Lipedema; Metabolism

Keywords

Lipedema; Metabolism; Body Composition; Fat Distribution; Immunology

Outcome Measures

Primary Outcomes (2)

• Change in thigh subcutaneous adipose tissue volume

  Thigh subcutaneous adipose tissue volume assessed by magnetic resonance imaging.

  Before and after 5-10% weight loss (3-4 months)

• Whole-body insulin sensitivity

  Whole-body insulin sensitivity determined by using the hyperinsulinemic-euglycemic clamp procedure between women with obesity and women with obesity and lipedema.

  Baseline testing

Secondary Outcomes (6)

• Thigh subcutaneous adipose tissue volume

  Baseline testing

• Change in whole-body insulin sensitivity

  Before and after 5-10% weight loss (3-4 months)

• Leg fat mass

  Baseline testing

• Change in leg fat mass

  Before and after 5-10% weight loss (3-4 months)

• Adipose tissue immune cells

  Baseline testing

Other Outcomes (3)

• Adipose tissue transcriptomics

  Baseline testing

• Change in abdominal subcutaneous adipose tissue transcriptomics

  Before and after 5-10% weight loss (3-4 months)

• Change in thigh subcutaneous adipose tissue transcriptomics

  Before and after 5-10% weight loss (3-4 months)

Study Arms (2)

Lean women with Lipedema

EXPERIMENTAL

Body composition, adipose tissue biology, insulin sensitivity assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.

Dietary Supplement: Weight loss

Women with Obesity and Lipedema

EXPERIMENTAL

Body composition, adipose tissue biology, insulin sensitivity and immune function/inflammation assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.

Dietary Supplement: Weight loss

Interventions

Weight loss DIETARY_SUPPLEMENT

Participants will lose weight by utilizing a low caloric diet and meeting with a study dietitian and/or behaviorist weekly for \~4 months.

Lean women with Lipedema; Women with Obesity and Lipedema

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Lipedema Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Cifarelli V, Smith GI, Gonzalez-Nieves S, Samovski D, Palacios HH, Yoshino J, Stein RI, Fuchs A, Wright TF, Klein S. Adipose Tissue Biology and Effect of Weight Loss in Women With Lipedema. Diabetes. 2025 Mar 1;74(3):308-319. doi: 10.2337/db24-0890.

  PMID: 39652636 RESULT

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: August 1, 2017
• Primary Completion: March 28, 2023
• Study Completion: March 24, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Before publication of manuscript containing RNA sequencing results
• Access Criteria: RNA sequencing results will be publicly available.

Locations

US (1)