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: June 25, 2014
Last verified: June 2014
  Purpose

This pilot study is using a novel technology to measure the rate of turnover of new fat cells. There is currently one active phase of this study. It involves a 1-day (no overnight) stay in the hospital, and 3 fat biopsies over a 6 month period. The study is ongoing, but is currently not enrolling new volunteers.


Condition Intervention
Healthy
Biological: 15N-Thymidine, 2H-Water

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quantification of Human Adipogenesis

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Quantifying human adipogenesis-counting the number of new fat cells. [ Time Frame: 4 weeks-7 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Fat biopsy. Oral mucosal smear. White blood cells.


Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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).


  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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
Study First Received: December 9, 2010
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
No specific experimental conditions

ClinicalTrials.gov processed this record on August 21, 2014