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Quantification of Human Adipogenesis

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ClinicalTrials.gov Identifier: NCT01257997
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Steinhauser, MD, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment
Healthy Biological: 15N-Thymidine, 2H-Water

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Quantification of Human Adipogenesis
Study Start Date : December 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

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.
Biological: 15N-Thymidine, 2H-Water

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).




Primary Outcome Measures :
  1. Quantifying human adipogenesis-counting the number of new fat cells. [ Time Frame: 4 weeks-7 months ]

Biospecimen Retention:   Samples Without DNA
Fat biopsy. Oral mucosal smear. White blood cells.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of illicit substance abuse.
Criteria

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.

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): NCT01257997


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Matthew L Steinhauser, MD Brigham and Women's Hospital

Publications of Results:
Responsible Party: Matthew Steinhauser, MD, Attending Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01257997     History of Changes
Other Study ID Numbers: BWH-2010p001900
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Matthew Steinhauser, MD, Brigham and Women's Hospital:
No specific experimental conditions