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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00229268
First received: September 27, 2005
Last updated: May 31, 2012
Last verified: May 2012
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FOXA2 Expression in Adipose Tissue of Human Subjects With Obesity/Insulin-Resistance

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Estimated Enrollment: 14
Study Start Date: September 2005
Study Completion Date: April 2010
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:

  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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00229268     History of Changes
Other Study ID Numbers: MST-0513
Study First Received: September 27, 2005
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Healthy Volunteers

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014