NCT01257997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

6 years

First QC Date

December 9, 2010

Last Update Submit

January 25, 2018

Conditions

Healthy

Keywords

No specific experimental conditions

Outcome Measures

Primary Outcomes (1)

  • Quantifying human adipogenesis-counting the number of new fat cells.

    4 weeks-7 months

Study Arms (1)

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

Interventions

15N-Thymidine, 2H-WaterBIOLOGICAL

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

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers. Aged 18-49 years. Free of significant chronic medical illness. Free of illicit substance abuse.

You may qualify if:

  • Aged 18-49 years.
  • Healthy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 22246326RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fat biopsy. Oral mucosal smear. White blood cells.

Study Officials

  • Matthew L Steinhauser, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 10, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

US(1)