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

May 31, 2012 updated by: Rockefeller University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers of different BMI classifications

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST-0513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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