Quantification of Human Adipogenesis

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01257997

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Healthy	Biological: 15N-Thymidine, 2H-Water

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Quantification of Human Adipogenesis

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Quantifying human adipogenesis-counting the number of new fat cells. [4 weeks-7 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthew Steinhauser, MD, Attending Physician, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT01257997

Other Study ID Numbers:

BWH-2010p001900

First Posted:

Dec 10, 2010

Last Update Posted:

Jan 29, 2018

Last Verified:

Jan 1, 2018

Keywords provided by Matthew Steinhauser, MD, Attending Physician, Brigham and Women's Hospital

No specific experimental conditions

Study Results

No Results Posted as of Jan 29, 2018