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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 belowSelect...
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
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 moreSide effects data
From 2016 Phase 3 trial • 150 Patients • NCT0085660998%
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
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
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,689 Total Patients Enrolled
Samuel Klein, MDPrincipal InvestigatorWashington University School of Medicine
27 Previous Clinical Trials
2,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have gone through menopause naturally or due to medical reasons.I have had weight loss surgery in the past.I am a woman with a BMI between 30 and 50, and have lipedema.My cancer has been in remission for less than 5 years.I have been diagnosed with Type 2 Diabetes.I do not have severe diabetes, lung, kidney, or heart problems.I have been diagnosed with Polycystic Ovary Syndrome.I am not on medications that could interfere with the study or increase risk during it.I am a lean woman with lipedema, with a BMI between 19.5 and 26.I am a woman with a BMI between 30 and 50, and have lipedema.I have been diagnosed with Lipedema.I am able to understand and agree to the study on my own.I am a woman with lipedema and my BMI is between 19.5 and 26.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline Lipedema characterization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lipedema Patient Testimony for trial: Trial Name: NCT03271034 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I qualified to take part in this exploration?
"This medical trial requires 20 participants, who range from 18 to 68 years of age and have lipedema. In addition, they must either be lean women (BMI >19.5 kg/m² and <26.0 kg/m²) or obese women with lipedema (BMI >30.0 kg/m² and <50.0 kg/m²)."
Answered by AI
What is the aggregate amount of individuals participating in this research endeavor?
"Yes, clinicaltrials.gov confirms that this experiment is actively recruiting human subjects starting from August 1st 2017 and amended on March 8th 2022. A total of 20 individuals are need to be recruited across one site."
Answered by AI
Are there opportunities still available to join this experiment?
"Affirmative. According to clinicaltrials.gov, the search for prospective patients is ongoing - this trial was initially posted on August 1st 2017 and it most recently updated on March 8th 2022. 20 participants are needed from just one approved medical centre."
Answered by AI
Are any elderly participants accepted for this research?
"This clinical trial has set the age limit for participants between 18 and 68 years of age. Conversely, there are 19 trials that cater to people younger than eighteen while 183 other studies would be suitable for those above 65."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
Massachusetts
Indiana
Other
How old are they?
65+
18 - 65
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I’m hoping to find help. Because I have this condition. I have tried to get rid of my fat pads inside of knees and my fat nodules on my thighs. help.
PatientReceived 1 prior treatment
I am wanting a way to treat my medical condition that is not surgical, as I am doing my best with diet, exercise and compression.
PatientReceived 1 prior treatment
I recently learned I have Lipodema. I have tried losing weight in everyway imaginable. I am hoping there is something that can help. I also just want to learn and understand more about the diagnosis, so I thought being part of a trail would be a good way to gain knowledge. Thanks for your consideration. Tannis.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I am Canadian - would I still qualify? If required to come to site for treatment, how often and would expenses be covered?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Washington University School of Medicine: < 48 hours
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