ObesityMYTHNCT02654925
Myeloid to Adipocyte Transdifferentiation in Human Cells
An observational study of Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adipose Tissue Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Obesity
- Being tested
- Adipose Tissue Biopsy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Tissue BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Young Men | men 21-40 years of age Receives: Procedure: Adipose Tissue Biopsy | |
| Young Women | women 21-40 years of age; young women will be premenopausal and eumenorrheic, not on hormonal contraceptive therapy. Receives: Procedure: Adipose Tissue Biopsy | |
| Older Men | men 55-100 years of age Receives: 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). Receives: Procedure: Adipose Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipogenic potential as measured by Oil Red-O staining (quantification by absorbance).
Measured: Within 60 days of biopsy
Adipocyte specific gene expression will be measured by qPCR (quantitative polymerase chain reaction) to confirm adipocyte status.
Measured: Sample collection within 60 days of biopsy, batched analysis completed depending on enrollment.
Secondary outcomes (3)
Assessment of the fraction of myeloid cells that become 'mesenchymal-like' (CD45-/CD14-/CD34+) (CD: cluster of differentiation) after fibrin culture by flow cytometry.
Measured: Within 2 weeks of biopsy
Progenitor cell proliferation capacity as measured by BrdU (bromodeoxyuridine) incorporation
Measured: Within 60 days of biopsy
In vivo adipogenesis in the Matrigel plug will be assessed by immunohistochemistry (IHC) for adipocyte (e.g., adiponectin) and nuclear markers (e.g., DAPI).
Measured: Samples will be collected within 60 days of biopsy, batched sample analysis will occur dependent on subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen M Gavin, PhD, Principal investigator, University of Colorado Denver Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654925
- Sponsor's protocol ID
- 15-1779
- Other IDs
- UL1TR001082
- Acronym
- MYTH
- Status last verified
- Jun 2021
- First submitted
- 7 Jan 2016
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid to Adipocyte Transdifferentiation in Human Cells
- ClinicalTrials.gov ID
- NCT02654925
- Acronym / sponsor ID
- MYTH / 15-1779
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Men | – | Procedure: Adipose Tissue Biopsymen 21-40 years of age |
| Young Women | – | Procedure: Adipose Tissue Biopsywomen 21-40 years of age; young women will be premenopausal and eumenorrheic, not on hormonal contraceptive therapy. |
| Older Men | – | Procedure: Adipose Tissue Biopsymen 55-100 years of age |
| Older Women | – | Procedure: Adipose Tissue Biopsywomen 55-100 years of age; older women will be postmenopausal who are at least 12 months past the final menstrual period (FMP). |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose Tissue Biopsy | Procedure or surgery | Older Men, Older Women, Young Men, Young Women |
Primary outcome
Adipogenic potential as measured by Oil Red-O staining (quantification by absorbance).
Time frame: Within 60 days of biopsy
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.
3 secondary outcomes
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
Progenitor cell proliferation capacity as measured by BrdU (bromodeoxyuridine) incorporation
Time frame: Within 60 days of biopsy
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Gavin, PhD principal investigator
University of Colorado Denver Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipogenic potential as measured by Oil Red-O staining (quantification by absorbance). (time frame: Within 60 days of biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.