- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257997
Quantification of Human Adipogenesis
January 25, 2018 updated by: Matthew Steinhauser, MD, Brigham and Women's Hospital
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 Overview
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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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
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers.
Aged 18-49 years.
Free of significant chronic medical illness.
Free of illicit substance abuse.
Description
Inclusion Criteria:
- Aged 18-49 years.
- Healthy.
Exclusion Criteria:
- 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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quantifying human adipogenesis-counting the number of new fat cells.
Time Frame: 4 weeks-7 months
|
4 weeks-7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthew L Steinhauser, MD, Brigham and Women's Hospital
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.
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
December 1, 2010
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
December 9, 2010
First Submitted That Met QC Criteria
December 9, 2010
First Posted (Estimate)
December 10, 2010
Study Record Updates
Last Update Posted (Actual)
January 29, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BWH-2010p001900
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.