Insight Into Subcutaneous Adipose Tissue Disorders (INSIGHT)

September 14, 2017 updated by: KHerbst, University of Arizona

Insight Into Subcutaneous Adipose Tissue Disorders As Part of The TREAT Program (Treatment, Research, Education, Adipose Tissue) at the University of Arizona

The INSIGHT study aims to phenotype individuals with subcutaneous adipose tissue (SAT) disorders specifically lipedema and Dercum's disease with an aim to find a cure for the SAT in these disorders that is resistant to diet and exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Lipedema is a syndrome of painful fatty enlargement of the buttocks, hips and thighs primarily in women which cannot be lost by diet, exercise or bariatric surgery. Arms are affected in 80% of women with lipedema to varying degrees. The etiology of lipedema is not known and there are no evidence-based treatments that work for a majority of individuals except for excision of the subcutaneous adipose tissue (SAT) by liposuction which has risks. Millions of women are affected with lipedema yet they are grossly under-diagnosed, have mobility issues and can develop lymphedema. The goal of this project is to better understand the etiology of lipedema SAT, find out how it is different from non-lipedema SAT, to improve our ability to identify the abnormal SAT and determine the response of the tissue to therapeutics by imaging and biomarkers. People with diffuse Dercum's disease (DD) appear to have lipedema plus a tissue inflammation that causes illness and pain. People with SAT disorders that have similarities to lipedema will also be included in this protocol. More research is needed to determine how these fatty disorders are similar and different from each other and from obesity so they can be distinguished clinically and by laboratory testing and imaging. Since these painful fatty disorders are associated with SAT growth, research focused on these disorders may provide unique insight into mechanisms of obesity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85714
        • Recruiting
        • University of Arizona College of Medicine (South Campus)
        • Contact:
        • Principal Investigator:
          • Karen L Herbst, MD, PhD
        • Sub-Investigator:
          • Sara Al-Ghadban, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women with lipedema and Dercum's disease and controls.

Description

Inclusion Criteria:

  1. Ambulatory males and/or females of any race able to understand the consent process.
  2. 19-70 years of age.
  3. Diagnosis of lipedema, Dercum's disease or familial multiple lipomatosis or other similar fat disorder.
  4. Individuals without a fat disorder (will be matched by age, sex, race and body mass index to individuals in "2").
  5. Weight stable for past three months within a 10 pound range per personal report of the subject.
  6. Overweight or obese (BMI > 26 kg/m2) in order to be able to get enough SAT for the biopsy.
  7. Individuals with BMI < 26 kg/m2 may participate in all aspects of the study protocol except the SAT biopsy.
  8. Thyroid levels in the normal range as confirmed by a TSH level. May have treated hypothyroidism that is stable over 6 months.

Exclusion Criteria:

  1. HIV infection (because of the associated lipodystrophy and fatty growths [lipomas]).
  2. Subjects will be excluded from having a SAT biopsy with any history of scleroderma, keloid formation or other skin condition that would result in substantial scarring after biopsy, a history of recurrent cellulitis, any history of bleeding diathesis that would place the subject at great risk for persistent bleeding after a biopsy/liposuction, any history of major complication after a previous biopsy including requirement of a blood transfusion, hospitalization, failure to heal, or major infection, requiring intravenous antibiotics, or anyone whose skin and tissue would put them at risk for an infection after the biopsy per the assessment of study staff and the principal investigator. These individuals may participate in the remainder of the protocol, just not the SAT biopsy.
  3. Use of any immunosuppressant or corticosteroid medication.
  4. Use of any anti-inflammatory medication such as NSAIDs, aspirin, histamine (H) 1 blocker, H2 blocker, tetracycline or corticosteroids within five days of the study procedure visit.
  5. Use of medications that might cause weight gain (e.g., second generation anti-psychotics).
  6. Blood donation less than 56 days prior to screening visit.
  7. Tobacco or marijuana use which may alter inflammation in the body.
  8. Any antibiotics within the last month.
  9. Barium enema in the last week which would affect gut bacteria and the MRI.
  10. Pregnancy due to the risks associated with the fat biopsy in the area of the fetus and because pregnancy will alter hormone levels.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Lipedema
Women with all stages of lipedema
Dercum's disease
Men and women with nodular, mixed and diffuse Dercum's disease
Control
Sex, age and BMI matched controls.
Familial Multiple Lipomatosis
Women and men with multiple lipomas and/or angiolipomas
Madelung's disease
Men and women with different types of Madelung's disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Transcriptomics of all enrolled subjects from a single timepoint to assess for changes in gene expression in lipedema tissue compared to controls
Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
This is a phenotyping study that collects data as a single time point though studies may occur on different days.
Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
Metabolomics of all enrolled subjects from a single timepoint to assess for changes in metabolites in lipedema tissue compared to controls
Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
This is a phenotyping study that collects data as a single time point though studies may occur on different days.
Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
Lipidomics of all enrolled subjects from a single timepoint to assess for changes in lipid particles in lipedema tissue and blood compared to controls
Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
This is a phenotyping study that collects data as a single time point though studies may occur on different days.
Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
Cytokines of all enrolled subjects from a single timepoint to assess for changes in cytokine arrays in lipedema tissue and blood compared to controls
Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
This is a phenotyping study that collects data as a single time point though studies may occur on different days.
Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
Myostatin of all enrolled subjects from a single timepoint to assess for levels of myostatin in lipedema tissue and blood compared to controls
Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
This is a phenotyping study that collects data as a single time point though studies may occur on different days.
Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lipedema Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen L Herbst, PhD, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1602399502A001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data will be shared with investigators who submit a request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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