HealthyNCT01257997
Quantification of Human Adipogenesis
An observational study of Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This pilot study is using a novel technology to measure the rate of turnover of new fat cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling new volunteers. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 15N-Thymidine, 2H-Water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2017
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of illicit substance abuse.
Who may be able to join
- Aged 18-49 years.
- Healthy.
Who cannot join
- Significant chronic medical illness.
- Illicit substance or alcohol abuse.
- Body mass index > 27 kg/meters squared.
- Underweight (BMI < 20 kg/m2).
- History of keloid formation (excessive scarring).
- Pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This pilot study is using a novel technology to measure the rate of turnover of new fat cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling new volunteers.
- Conditions
- Healthy
- Being tested
- 15N-Thymidine, 2H-Water
- Keywords
- No specific experimental conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15N-Thymidine, 2H-WaterBiological
Stable isotope 15N-thymidine, infused IV (15mg/hour) for 72 hours (phase 1 pilot).
Stable isotope 2H-water, ingested by mouth once per day for 3 days (phase 1 pilot) or 28 days (phase 2 pilot).
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 18-49 year old healthy men and women. Free of significant chronic medical illness and illicit substance abuse. Body mass index from 20 to 27. Receives: Biological: 15N-Thymidine, 2H-Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantifying human adipogenesis-counting the number of new fat cells.
Measured: 4 weeks-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Steinhauser, MD, Brigham and Women's Hospital
- Investigators
- Matthew L Steinhauser, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257997
- Sponsor's protocol ID
- BWH-2010p001900
- Status last verified
- Jan 2018
- First submitted
- 9 Dec 2010
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinhauser ML, Bailey AP, Senyo SE, Guillermier C, Perlstein TS, Gould AP, Lee RT, Lechene CP. Multi-isotope imaging mass spectrometry quantifies stem cell division and metabolism. Nature. 2012 Jan 15;481(7382):516-9. doi: 10.1038/nature10734.
PubMed 22246326
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Human Adipogenesis
- ClinicalTrials.gov ID
- NCT01257997
- Acronym / sponsor ID
- BWH-2010p001900
- Conditions
- Healthy
- Keywords
- No specific experimental conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Dec 2010 (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.
This pilot study is using a novel technology to measure the rate of turnover of new fat cells. Analysis of volunteer samples is ongoing, however the study is currently not enrolling new volunteers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Biological: 15N-Thymidine, 2H-Water18-49 year old healthy men and women. Free of significant chronic medical illness and illicit substance abuse. Body mass index from 20 to 27. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of illicit substance abuse.
Key inclusion criteria (2 listed)
- Aged 18-49 years.
- Healthy.
Key exclusion criteria (6 listed)
- Significant chronic medical illness.
- Illicit substance or alcohol abuse.
- Body mass index > 27 kg/meters squared.
- Underweight (BMI < 20 kg/m2).
- History of keloid formation (excessive scarring).
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 |
|---|---|---|
| 15N-Thymidine, 2H-WaterStable isotope 15N-thymidine, infused IV (15mg/hour) for 72 hours (phase 1 pilot). Stable isotope 2H-water, ingested by mouth once per day for 3 days (phase 1 pilot) or 28 days (phase 2 pilot). | Biological | Healthy subjects |
Primary outcome
Quantifying human adipogenesis-counting the number of new fat cells.
Time frame: 4 weeks-7 months
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 29 Jan 2018.
- Results publication: PubMed 22246326Steinhauser ML, Bailey AP, Senyo SE, Guillermier C, Perlstein TS, Gould AP, Lee RT, Lechene CP. Multi-isotope imaging mass spectrometry quantifies stem cell division and metabolism. Nature. 2012 Jan 15;481(7382):516-9. doi: 10.1038/nature10734.
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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.
Matthew L Steinhauser, MD principal investigator
Brigham and Women's Hospital
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 Healthy, run by Brigham and Women's Hospital 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 2 inclusion and 6 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 29 Jan 2018. 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?
Quantifying human adipogenesis-counting the number of new fat cells. (time frame: 4 weeks-7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257997, which also lists 1 linked publication.
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 29 Jan 2018.