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Myeloid to Adipocyte Transdifferentiation in Human Cells (MYTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654925
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
In order to design new programs to help prevent weight gain, promote successful and sustainable weight loss, and help treat diseases related to obesity, the investigators need a better understanding of why accumulating fat in certain regions of the body is bad for health. It is known that not all fat cells are the same, but it was recently discovered that some fat cells may arise from stem cells that come from the bone marrow (bone marrow progenitors), a previously unrecognized origin. This discovery has been paradigm shifting, because dogma has long held that all white fat cells arise from fat tissue resident mesenchymal stem cells. This is also important because fat cells arising from the bone marrow lineage may be linked to worse health outcomes. The aim of this study is to determine if cells that were not previously believed to contribute to fat generation in humans are indeed capable of becoming fat cells. To answer this question the investigators will take samples of cells from the blood and the fat tissue of younger and older men and women, isolate the cells that came from the bone marrow and grow them in culture to determine if they will turn into fat cells. The results of this investigation may reveal potential mechanistic targets for future therapies to reduce the negative health outcomes associated with obesity related chronic diseases.

Condition or disease Intervention/treatment
Obesity Procedure: Adipose Tissue Biopsy

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Myeloid to Adipocyte Transdifferentiation in Human Cells
Study Start Date : March 2016
Actual Primary Completion Date : June 15, 2021
Actual Study Completion Date : June 15, 2021

Group/Cohort Intervention/treatment
Young Men
men 21-40 years of age
Procedure: Adipose Tissue Biopsy
Young Women
women 21-40 years of age; young women will be premenopausal and eumenorrheic, not on hormonal contraceptive therapy.
Procedure: Adipose Tissue Biopsy
Older Men
men 55-100 years of age
Procedure: Adipose Tissue Biopsy
Older Women
women 55-100 years of age; older women will be postmenopausal who are at least 12 months past the final menstrual period (FMP).
Procedure: Adipose Tissue Biopsy



Primary Outcome Measures :
  1. Adipogenic potential as measured by Oil Red-O staining (quantification by absorbance). [ Time Frame: Within 60 days of biopsy ]
  2. Adipocyte specific gene expression will be measured by qPCR (quantitative polymerase chain reaction) to confirm adipocyte status. [ Time Frame: Sample collection within 60 days of biopsy, batched analysis completed depending on enrollment. ]

Secondary Outcome Measures :
  1. Assessment of the fraction of myeloid cells that become 'mesenchymal-like' (CD45-/CD14-/CD34+) (CD: cluster of differentiation) after fibrin culture by flow cytometry. [ Time Frame: Within 2 weeks of biopsy ]
  2. Progenitor cell proliferation capacity as measured by BrdU (bromodeoxyuridine) incorporation [ Time Frame: Within 60 days of biopsy ]
  3. In vivo adipogenesis in the Matrigel plug will be assessed by immunohistochemistry (IHC) for adipocyte (e.g., adiponectin) and nuclear markers (e.g., DAPI). [ Time Frame: Samples will be collected within 60 days of biopsy, batched sample analysis will occur dependent on subject enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Men and women age 21-40 y or 55-100 y;
  • Older women will be postmenopausal who are at least 12 months past the final menstrual period (FMP);
  • Young women will be premenopausal and eumenorrheic, not on hormonal contraceptive therapy;
  • Body Mass Index (BMI) 22-35 kg/m2;
  • Non-active to moderately active (vigorous exercise ≤ 3 days/wk lasting < 30 min).

Exclusion Criteria:

  • Immunosuppression therapy;
  • On blood thinners, aspirin, or NSAIDs that cannot be withheld for the biopsy;
  • Prior history of allergies to local anesthetics;
  • Current use of hormones, or glucose lowering medication;
  • Currently engaged in a vigorous exercise or diet program;
  • Currently gaining or losing weight or using weight loss drugs;
  • Type 2 diabetes (past/current diagnosis or treatment);
  • Diagnosis of uncontrolled metabolic disorders (e.g., thyroid);
  • History of severe obesity BMI ≥ 40 or significant weight loss (≥ 50 lbs);
  • Postmenopausal - hormonal menopausal therapy use currently or in the previous 6 months;
  • Premenopausal - irregular menstrual cycles defined as 2 or more missed cycles in the previous year, pregnant or planning to become pregnant during the study timeline (urine pregnancy test will be performed before DEXA [dual energy x-ray absorptiometry] scan is completed).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654925


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Kathleen M Gavin, PhD University of Colorado Denver Anschutz Medical Campus
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02654925    
Other Study ID Numbers: 15-1779
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No