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OpenTrials
Completed

NCT Number: NCT02654925

Myeloid to Adipocyte Transdifferentiation in Human Cells

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.

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adipose tissue biopsy

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: MYTH

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2016
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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