Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 68 |
| Updated: | 7/5/2018 |
| Start Date: | August 1, 2017 |
| End Date: | June 2021 |
| Contact: | Vincenza Cifarelli, PhD |
| Email: | cifarelli@wustl.edu |
| Phone: | 314-273-1386 |
Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the
waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain
and accumulation of fluid. Little is known about the functional changes that lead to fat
accumulation and pain in women with lipedema. The goals of this project is to conduct a
comprehensive characterization of abdominal and femoral fat tissues from women with lipedema
and to evaluate the potential effect of a diet-induced weight loss as a therapy.
Once enrolled in the study, the following tests will be conducted on lipedema subjects: 1)
characterization of body composition (fat tissue distribution), insulin sensitivity (response
to insulin), adipose tissue biology, and vascular function (how arteries dilate/contract) and
immune system function/inflammation. As control, we will have two control populations:
BMI-matched women that are metabolically normal obese (MNO) and Metabolically Abnormal Obese
(MAO) already analyzed in different studies at Washington University (IRB# 201512086 and
201610005). The MAO and MNO subjects underwent the same testing described above for the
lipedema. Therefore, we will use the data generated from IRB# 201512086 and 201610005 as
comparison groups in the statistical analysis to understand differences and similarities
between lipedema and obesity.
A second aim of the study is to determine the effect of diet-induced weight loss on body
composition, insulin sensitivity, adipose tissue biology, and vascular function in the women
with lipedema and compare these results with data obtained from BMI-matched women with MAO
participating in another study at Washington University (IRB# 201512086). The MAO population
will be used as control populations and data generated from the IRB# 201512086 will be used
as comparison group for statistical analysis. The results from this second aim of the study
will hopefully provide important insights on the efficacy of diet therapy in managing
lipedema.ed
waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain
and accumulation of fluid. Little is known about the functional changes that lead to fat
accumulation and pain in women with lipedema. The goals of this project is to conduct a
comprehensive characterization of abdominal and femoral fat tissues from women with lipedema
and to evaluate the potential effect of a diet-induced weight loss as a therapy.
Once enrolled in the study, the following tests will be conducted on lipedema subjects: 1)
characterization of body composition (fat tissue distribution), insulin sensitivity (response
to insulin), adipose tissue biology, and vascular function (how arteries dilate/contract) and
immune system function/inflammation. As control, we will have two control populations:
BMI-matched women that are metabolically normal obese (MNO) and Metabolically Abnormal Obese
(MAO) already analyzed in different studies at Washington University (IRB# 201512086 and
201610005). The MAO and MNO subjects underwent the same testing described above for the
lipedema. Therefore, we will use the data generated from IRB# 201512086 and 201610005 as
comparison groups in the statistical analysis to understand differences and similarities
between lipedema and obesity.
A second aim of the study is to determine the effect of diet-induced weight loss on body
composition, insulin sensitivity, adipose tissue biology, and vascular function in the women
with lipedema and compare these results with data obtained from BMI-matched women with MAO
participating in another study at Washington University (IRB# 201512086). The MAO population
will be used as control populations and data generated from the IRB# 201512086 will be used
as comparison group for statistical analysis. The results from this second aim of the study
will hopefully provide important insights on the efficacy of diet therapy in managing
lipedema.ed
Once informed consent has been obtained, participants will complete 1 screening visit.
Screen Visit includes a medical history, physical examination, pregnancy test (for women of
childbearing potential), blood tests, urine drug test, an oral glucose tolerance test,
resting electrocardiogram (ECG), questionnaires.
Baseline testing will be performed in 7 weekly visits requiring 1 inpatient overnight stay
and will require ~30h to complete testing. Testing will include imaging scans to determine
leg muscle mass, abdominal (belly) fat mass and liver fat content; DXA scan, blood samples,
skin temperature monitoring, hyperinsulinemic-euglycemic clamp procedure, immune system
function/inflammation, adipose tissue and muscle biopsies, adipose tissue oxygenation
assessment, vascular compliance testing (arterial stiffness and endothelial function).
Once Baseline Testing is completed, participants will start 8-10% dietitian guided
weight-loss for about 4 months with all meals provided.
Participant will have weekly visits with a study dietitian.
After weight loss, the testing completed during baseline will be repeated during Visit 25.
Study procedures:
1. Medical History & Physical Exam
2. Urine Drug/Pregnancy Test
3. Blood pressure, pulse, height, weight, shoulder and waist circumference measurements
4. Electrocardiogram (ECG)
5. Blood tests for routine lab analyses
6. Oral Glucose Tolerance Test (OGTT)
7. Screening Questionnaires
8. Food Diary
9. Deuterated water consumption
10. Dual energy X-ray absorptiometry (DEXA)
11. Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) for Body
Composition to determine 1)the amount of fat in the liver, abdomen (belly), and lower
leg; 2)the amount of oxygen in the abdominal fat store; and 3)how much muscle mass is in
the thigh
12. Metabolism study (hyperinsulinemic euglycemic clamp procedure)
13. Resting Energy Expenditure (REE)
14. Abdominal and Thigh Fat biopsies
15. Muscle biopsies
16. Skin temperature monitoring
17. Cardiovascular testing: Carotid artery intima-media thickness (CIMT); Pulse wave
velocity (SphygmoCor); Endothelial function (Endopat)
Screen Visit includes a medical history, physical examination, pregnancy test (for women of
childbearing potential), blood tests, urine drug test, an oral glucose tolerance test,
resting electrocardiogram (ECG), questionnaires.
Baseline testing will be performed in 7 weekly visits requiring 1 inpatient overnight stay
and will require ~30h to complete testing. Testing will include imaging scans to determine
leg muscle mass, abdominal (belly) fat mass and liver fat content; DXA scan, blood samples,
skin temperature monitoring, hyperinsulinemic-euglycemic clamp procedure, immune system
function/inflammation, adipose tissue and muscle biopsies, adipose tissue oxygenation
assessment, vascular compliance testing (arterial stiffness and endothelial function).
Once Baseline Testing is completed, participants will start 8-10% dietitian guided
weight-loss for about 4 months with all meals provided.
Participant will have weekly visits with a study dietitian.
After weight loss, the testing completed during baseline will be repeated during Visit 25.
Study procedures:
1. Medical History & Physical Exam
2. Urine Drug/Pregnancy Test
3. Blood pressure, pulse, height, weight, shoulder and waist circumference measurements
4. Electrocardiogram (ECG)
5. Blood tests for routine lab analyses
6. Oral Glucose Tolerance Test (OGTT)
7. Screening Questionnaires
8. Food Diary
9. Deuterated water consumption
10. Dual energy X-ray absorptiometry (DEXA)
11. Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) for Body
Composition to determine 1)the amount of fat in the liver, abdomen (belly), and lower
leg; 2)the amount of oxygen in the abdominal fat store; and 3)how much muscle mass is in
the thigh
12. Metabolism study (hyperinsulinemic euglycemic clamp procedure)
13. Resting Energy Expenditure (REE)
14. Abdominal and Thigh Fat biopsies
15. Muscle biopsies
16. Skin temperature monitoring
17. Cardiovascular testing: Carotid artery intima-media thickness (CIMT); Pulse wave
velocity (SphygmoCor); Endothelial function (Endopat)
Inclusion Criteria:
- Diagnosis of Lipedema
- BMI > 30.0 kg/m^2 and <50.0 kg/m^2
Exclusion Criteria:
- Medical, surgical or biological menopause
- Previous bariatric surgery
- Diagnosis of Type 2 Diabetes
- HbA1C <5.7%
- Structured exercise >2 days/week for >/= 35 minutes of intense exercise (e.g.,
jogging, activity that cause heavy breathing and sweating) or >/=150 minutes per week
of structured exercise (e.g., brisk walking)
- Unstable weight (>4% change in weight during the last 2 months before entering the
study)
- Significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or
cardiovascular disease)
- Cancer or cancer that has been in remission for <5 years
- Polycystic Ovary Syndrome
- Major psychiatric illness
- Conditions that render participant unable to complete all testing procedures (e.g.,
severe ambulatory impairments, limb amputations, or metal implants that interfere with
imaging procedures; coagulation disorders)
- Use of medications that are know to affect the study outcome measures (e.g., steroids,
non-statin lipid-lowering medications) or increase the risk of study procedures (e.g.,
anticoagulants) and that cannot be temporarily discontinued for this study
- Smoke cigarettes >10 cigarettes/week
- Consume >14 units of alcohol per week
- Pregnant or lactating women
- Vegans
- Persons who are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who, for any
reason, the research team considers not an appropriate candidate for this study,
including non-compliance with screening appointments or study visits.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Samuel Klein, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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