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Weight Loss for Lipedema (Lipedema Trial)

N/A
Waitlist Available
Led By Samuel Klein, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with obesity and lipedema (BMI >30.0 kg/m² and <50.0 kg/m²)
Diagnosis of Lipedema
Must not have
Medical, surgical or biological menopause
Previous bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 5-10% weight loss (3-4 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial involves lean and obese women with lipedema following a dietitian-guided weight loss plan. The goal is to see if losing weight can improve fat distribution, overall health, and potentially reduce pain and fat buildup in the legs.

Who is the study for?
This trial is for women with lipedema, a condition causing abnormal fat accumulation in the legs. Eligible participants include lean women (BMI between 19.5 and 26) and those with obesity (BMI between 30 and 50), without type 2 diabetes, significant organ dysfunction, or recent cancer. They shouldn't have had bariatric surgery or be on certain medications.
What is being tested?
The study investigates how diet-induced weight loss affects body composition, insulin sensitivity, and fat tissue biology in women with lipedema. It involves comprehensive testing against control groups to understand the impact of weight loss as a potential therapy for managing lipedema.
What are the potential side effects?
While not explicitly stated, potential side effects may include typical reactions to dietary changes such as fatigue, digestive discomforts like bloating or constipation, nutrient deficiencies if not monitored properly, and psychological impacts due to lifestyle alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman with a BMI between 30 and 50, and have lipedema.
Select...
I have been diagnosed with Lipedema.
Select...
I am a woman with lipedema and my BMI is between 19.5 and 26.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have gone through menopause naturally or due to medical reasons.
Select...
I have had weight loss surgery in the past.
Select...
My cancer has been in remission for less than 5 years.
Select...
I have been diagnosed with Type 2 Diabetes.
Select...
I do not have severe diabetes, lung, kidney, or heart problems.
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I have been diagnosed with Polycystic Ovary Syndrome.
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I am not on medications that could interfere with the study or increase risk during it.
Select...
I am able to understand and agree to the study on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after 5-10% weight loss (3-4 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 5-10% weight loss (3-4 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in thigh subcutaneous adipose tissue volume
Whole-body insulin sensitivity
Secondary study objectives
Adipose tissue immune cells
Change in adipose tissue immune cells
Change in leg fat mass
+3 more
Other study objectives
Adipose tissue transcriptomics
Change in adipose tissue transcriptomics

Side effects data

From 2016 Phase 3 trial • 150 Patients • NCT00856609
98%
hunger decrease
60%
Nausea
57%
Headache
40%
Diarrhea
35%
Constipation
33%
Injection site reaction
33%
Gastroesophageal reflux
30%
Itchiness
28%
Vomiting
25%
hypoglycemia
15%
Skin rash
10%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Exenatide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Women with Obesity and LipedemaExperimental Treatment1 Intervention
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.
Group II: Lean women with LipedemaExperimental Treatment1 Intervention
Body composition, adipose tissue biology, insulin sensitivity assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weight loss
2010
Completed Phase 4
~1790

Find a Location

Who is running the clinical trial?

Lipedema FoundationOTHER
4 Previous Clinical Trials
817 Total Patients Enrolled
4 Trials studying Lipedema
817 Patients Enrolled for Lipedema
Washington University School of MedicineLead Sponsor
1,984 Previous Clinical Trials
2,291,700 Total Patients Enrolled
Samuel Klein, MDPrincipal InvestigatorWashington University School of Medicine
28 Previous Clinical Trials
2,257 Total Patients Enrolled

Media Library

Mediterranean diet Clinical Trial Eligibility Overview. Trial Name: NCT03271034 — N/A
Lipedema Research Study Groups: Lean women with Lipedema, Women with Obesity and Lipedema
Lipedema Clinical Trial 2023: Mediterranean diet Highlights & Side Effects. Trial Name: NCT03271034 — N/A
Mediterranean diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03271034 — N/A
Lipedema Patient Testimony for trial: Trial Name: NCT03271034 — N/A
~0 spots leftby Dec 2024
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