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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

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I am a woman with a BMI between 30 and 50, and have lipedema.

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I have been diagnosed with Lipedema.

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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:

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I have gone through menopause naturally or due to medical reasons.

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I have had weight loss surgery in the past.

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My cancer has been in remission for less than 5 years.

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I have been diagnosed with Type 2 Diabetes.

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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.

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I am able to understand and agree to the study on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after 5-10% weight loss (3-4 months)

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%

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

0 / 11Eligibility criteria met