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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months

Awards & highlights

Lipedema Trial Summary

This trial is looking at women with a disorder called lipedema, which causes them to store fat abnormally and have leg pain. They will be compared to similar women without the disorder to see what differences there are.

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.Check my eligibility

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.See study design

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.

Lipedema Trial 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.

Lipedema Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Composition and Fat distribution

Immune system function (obese women with lipedema and BMI-matched controls)

Metabolic function

+1 more

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%

Study treatment Arm

Placebo

Exenatide

Lipedema Trial Design

1Treatment groups

Experimental Treatment

Group I: Baseline Lipedema characterizationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Weight loss

2010

Completed Phase 4

~1790

0 / 3Eligibility criteria met