Weight Loss for Lipedema

(Lipedema Trial)

No longer recruiting at 1 trial location

Overseen By Nikki Plassmeyer, MA, RDN, LD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Steroids, Anticoagulants, others

Disqualifiers: Menopause, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the fat buildup and pain associated with lipedema, a condition causing excess fat and fluid in the legs. Researchers seek to determine how diet-induced weight loss, specifically through a Mediterranean diet, affects body composition and insulin sensitivity (how the body processes sugar) in women with lipedema. They will study both lean and obese women, comparing them to control groups without lipedema. Women diagnosed with lipedema who are either lean or obese, but without other major health issues like diabetes, might be a good fit for this study. As an unphased study, this trial offers a unique opportunity to contribute to foundational research that could enhance understanding and treatment of lipedema.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that could affect the study results, like steroids or certain cholesterol-lowering drugs, if they can't be temporarily stopped for the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Mediterranean diet is generally safe for most people. Studies have found that this diet can aid weight loss and improve overall health. One large study revealed that people who closely followed the Mediterranean diet lost a small amount of weight over several years, indicating its safety and tolerance.

Regarding weight loss through diet changes, research has shown that losing even a small amount of weight, about 3%, can reduce leg fat in people with lipedema. In a specific 20-week study, the Mediterranean diet helped participants lose weight and improve heart health. This type of weight loss through diet is generally safe for most people.

Overall, both the Mediterranean diet and weight loss strategies appear safe for most participants based on available studies. These studies report no serious side effects or negative outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lipedema because they focus on dietary strategies that could directly influence body composition and metabolic health. Unlike many standard treatments that primarily address symptoms through compression garments or surgical options like liposuction, the Mediterranean diet combined with weight loss aims to improve insulin sensitivity and reduce inflammation. This approach not only targets weight loss but also delves into the biology of adipose tissue, offering a potentially more holistic and sustainable method to manage the condition.

What evidence suggests that this trial's treatments could be effective for lipedema?

Research has shown that following a Mediterranean diet, which participants in this trial may adopt, can help reduce inflammation in people with lipedema. One study found that inflammation decreased after participants followed this diet. Another study discovered unexpected fat loss in the legs and arms after just four weeks on the diet. In this trial, participants will also engage in a weight loss program. A review of several studies noted that losing even a small amount of weight, about 3%, can reduce leg fat in people with lipedema. However, some studies suggest that while weight loss can improve overall health, it might not significantly change the unusual fat distribution seen in lipedema. Overall, these findings suggest possible benefits, but results can vary from person to person. ^{1 3 4 6 7}

Who Is on the Research Team?

Samuel Klein, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have been diagnosed with Lipedema.

I am a woman with lipedema and my BMI is between 19.5 and 26.

Exclusion Criteria

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

I have had weight loss surgery in the past.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Baseline testing including MRI, DXA scans, blood samples, and insulin sensitivity assessment

Approximately 30 hours over 2 visits

2 visits (1 inpatient overnight stay)

Diet-Induced Weight Loss

Participants undergo dietitian and/or behaviorist guided weight-loss to achieve 5-10% weight loss

4-6 months

Weekly visits (in-person or remote)

Post-Weight Loss Testing

Repeat of baseline testing to assess changes after weight loss

Approximately 30 hours over 2 visits

2 visits (1 inpatient overnight stay)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean diet
• Weight loss

Trial Overview

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.

How Is the Trial Designed?

Group I: Women with Obesity and Lipedema Experimental Treatment 1 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 Lipedema Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Lipedema Foundation

Collaborator

Trials

5

Recruited

840+

Published Research Related to This Trial

The Mediterranean Diet (MedDiet) has been linked to numerous health benefits, particularly in reducing the risk of cardiovascular diseases, metabolic disorders, and cancer, as evidenced by an increase in clinical trials over the last decade.

The diet's positive effects are largely attributed to its anti-inflammatory and antioxidant properties, with strict adherence and specific components like olive oil playing crucial roles in managing obesity and waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. Finicelli, M., Di Salle, A., Galderisi, U., et al.[2022]

A 6-month dietary intervention using the Italian Mediterranean Diet (IMD) in 80 patients with metabolic syndrome led to significant weight loss, with body weight decreasing from 102.59 kg to 92.39 kg and waist circumference reducing from 112.23 cm to 92.42 cm (p < 0.001).

The IMD also resulted in improved cardiometabolic health, with 52% of participants resolving their metabolic syndrome and significant reductions in blood pressure, fasting glucose, and harmful cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body composition changes and cardiometabolic benefits of a balanced Italian Mediterranean Diet in obese patients with metabolic syndrome. Di Daniele, N., Petramala, L., Di Renzo, L., et al.[2022]

A 20-week behavior program for 54 obese patients following a Mediterranean diet led to significant weight loss and improvements in cardiovascular risk factors and insulin sensitivity, despite a decrease in monounsaturated fatty acid intake.

The study found that while caloric restriction improved insulin sensitivity and reduced various health markers, the lipoprotein profile remained unchanged, suggesting that dietary modifications should carefully consider the balance of fats consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in nutritional pattern, insulin sensitivity and glucose tolerance during weight loss in obese patients from a Mediterranean area. Calle-Pascual, AL., Saavedra, A., Benedi, A., et al.[2011]

A Mediterranean diet supplemented with dairy foods significantly reduced systolic and diastolic blood pressure in participants at risk of cardiovascular disease, indicating improved cardiovascular health.

The MedDairy diet also led to favorable changes in cholesterol levels, including higher HDL cholesterol and lower triglycerides, suggesting it may be an effective dietary approach for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. Wade, AT., Davis, CR., Dyer, KA., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7911402/

Potential Effects of a Modified Mediterranean Diet on Body ...

95% of patients fail to lose weight in the lipoedema areas. The study was conducted to evaluate body composition and general health status ...

2.

mdpi.com

mdpi.com/2072-6643/17/18/3014

Exploring the Anti-Inflammatory Potential of a ...

In lipedema, baseline diet showed a pro-inflammatory DII profile (DII/day = 3.04), which was reduced by about 1.5 points after the intervention (p = 0.008).

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0378512225005249

Clinical or cultural? Dietary interventions for lipedema

Taken together, these data suggest that key outcomes of interest in lipedema interventions should also include mental health, eating behavior, and body image.

4.

researchgate.net

researchgate.net/publication/348776581_Potential_Effects_of_a_Modified_Mediterranean_Diet_on_Body_Composition_in_Lipoedema

(PDF) Potential Effects of a Modified Mediterranean Diet on ...

95% of patients fail to lose weight in the lipoedema areas. The study was conducted to evaluate body composition and general health status ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10457774/

Modified Mediterranean-Ketogenic Diet and Carboxytherapy ...

In our previous study, after four weeks of treatment, an unexpected significant loss of FM in the legs and arms was detected, resulting in the ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33504026/

Potential Effects of a Modified Mediterranean Diet on Body ...

95% of patients fail to lose weight in the lipoedema areas. The study was conducted to evaluate body composition and general health status ...

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/joim.13333

The Mediterranean diet and health: a comprehensive ...

In a report from the EPIC study including 373,803 men and women for a median of five years, individuals with high adherence to MedDiet lost 0.16 ...