Quantification of Human Adipogenesis

This study is currently recruiting participants.
Verified September 2013 by Brigham and Women's Hospital
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: September 11, 2013
Last verified: September 2013

December 9, 2010
September 11, 2013
December 2010
December 2014   (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. There are currently two active phases of this study.

  1. The first phase involves a 3-night stay in the hospital, and 2 fat biopsies over a one month period. The fat biopsies will be looked at under a special microscope that can tell which fat cells have been recently made.
  2. The second phase involves a 1-day (no overnight) stay in the hospital, and 3 fat biopsies over a 6 month period.
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Observational
Time Perspective: Prospective
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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 ass index from 20 to 27. Must be able to easily 'pinch an inch' of belly fat.
Intervention: Biological: 15N-Thymidine, 2H-Water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2015
December 2014   (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
Yes
Contact: Matthew L Steinhauser, MD 617 732 5500 ext 13202 msteinhauser@partners.org
United States
 
NCT01257997
BWH-2010p001900
No
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
September 2013

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