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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229268
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : June 1, 2012
Information provided by (Responsible Party):
Rockefeller University

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
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.

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Study Type : Observational
Estimated 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 : September 2005
Actual Study Completion Date : April 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers of different BMI classifications

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00229268

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United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
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Principal Investigator: Markus Stoffel, MD, PHD Rockefeller University

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Responsible Party: Rockefeller University Identifier: NCT00229268    
Other Study ID Numbers: MST-0513
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Rockefeller University:
Healthy Volunteers
Additional relevant MeSH terms:
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Insulin Resistance
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases