NCT00229268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

First QC Date

September 27, 2005

Last Update Submit

May 31, 2012

Conditions

Insulin ResistanceObesity

Keywords

Healthy Volunteers

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers of different BMI classifications

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Markus Stoffel, MD, PHD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Study Completion

April 1, 2010

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

US(1)