Research on the Nature, Diagnosis, and Treatment of Obesity and Diabetes - Full Text View

Sponsor:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00229268

Purpose

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
Insulin Resistance Obesity

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	FOXA2 Expression in Adipose Tissue of Human Subjects With Obesity/Insulin-Resistance

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	14
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2009

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.

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy volunteers of different BMI classifications

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229268

Locations

United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

Markus Stoffel, MD, PHD

Rockefeller University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Rockefeller University ( Allegra Grossman, MD )
Study ID Numbers:	MST-0513
Study First Received:	September 27, 2005
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00229268 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Rockefeller University:

Healthy Volunteers

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Hyperinsulinism
Obesity
Metabolic Diseases

Nutrition Disorders
Overweight
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010