Quantification of Human Adipogenesis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Matthew Steinhauser, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01257997
First received: December 9, 2010
Last updated: August 25, 2016
Last verified: August 2016

December 9, 2010
August 25, 2016
December 2010
December 2016   (final data collection date for primary outcome measure)
Quantifying human adipogenesis-counting the number of new fat cells. [ Time Frame: 4 weeks-7 months ] [ Designated as safety issue: No ]
Quantifying human adipogenesis-counting the number of new fat cells. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01257997 on ClinicalTrials.gov Archive Site
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Quantification of Human Adipogenesis
Quantification of Human Adipogenesis
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Fat biopsy. Oral mucosal smear. White blood cells.
Non-Probability Sample
Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of illicit substance abuse.
Healthy
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).

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2017
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257997
BWH-2010p001900
No
Not Provided
Not Provided
Matthew Steinhauser, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Matthew L Steinhauser, MD Brigham and Women's Hospital
Brigham and Women's Hospital
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP