Research on the Nature, Diagnosis, and Treatment of Obesity and Diabetes

Sponsor

Rockefeller University (Other)

Overall Status

Completed

CT.gov ID

NCT00229268

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the level of FOXA2 expression in fat tissue is a biomarker of insulin resistance. To test this hypothesis, we will perform euglycemic-hyperinsulinemic clamps in normal and obese human subjects to calculate insulin sensitivity, and see if insulin sensitivity correlates with the FOXA2 expression in subcutaneous fat.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Obesity

Detailed Description

The investigators at Rockefeller University Hospital are engaged in research on the nature, diagnosis and treatment of obesity and diabetes. The investigators are trying to find out why insulin, a blood sugar lowering hormone that is released by the pancreas following a meal, does not work effectively in individuals with obesity or type 2 diabetes. The investigators have recently discovered a protein in fat cells of obese mice that helps fat cells to take up and break down sugar from the blood. This protein (called FOXA2) also prevents the generation of more fat cells. FOXA2 is only present in obese mice, but absent from fat stores of lean animals. Insulin can stimulate the production of FOXA2 in fat cells. Furthermore, the levels of FOXA2 protein correlate with the degree of blood insulin levels. In this study, we are would like to determine whether FOXA2 is also produced in fat cells of humans, and if its level correlates with the degree of obesity and insulin resistance.

Study Design

Study Type:

Observational

Anticipated Enrollment :

14 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

FOXA2 Expression in Adipose Tissue of Human Subjects With Obesity/Insulin-Resistance

Study Start Date :

Sep 1, 2005

Actual Study Completion Date :

Apr 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy individuals
Age 21-45 years old
BMI: either < 25, or 30-35, or > 40
All patients must be willing and able to sign an informed consent form -

Exclusion Criteria:

Chronic illnesses other the than mild forms of illnesses related to obesity, such as hypertension, hyperlipidemia, and others, that do not require medical treatment
Diabetes mellitus previously diagnosed as per subject report or an abnormal 2 hour OGTT at screening
Chronic drug treatment for any medical condition
Active weight reduction of more than 7 pounds in the last 3 months
History of bleeding or blood clotting disorders
Subjects with hemoglobin <8.5 gm/dl
Changes in smoking habits for the last 6 months
Current pregnancy or current breast-feeding in women
Allergic reaction to local anesthetics
History of anaphylaxis or anaphylactic-like reactions
Tendency to form scars (keloids) easily
Irregular menses
HIV and hepatitis B or C positive subjects -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rockefeller University Hospital	New York	New York	United States	10021

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator: Markus Stoffel, MD, PHD, Rockefeller University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rockefeller University

ClinicalTrials.gov Identifier:

NCT00229268

Other Study ID Numbers:

MST-0513

First Posted:

Sep 29, 2005

Last Update Posted:

Jun 1, 2012

Last Verified:

May 1, 2012

Keywords provided by Rockefeller University

Healthy Volunteers

Additional relevant MeSH terms:

Obesity

Insulin Resistance

Study Results

No Results Posted as of Jun 1, 2012