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Fasting Predictors of OGTT and MMTT Response

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01998867
First Posted: December 2, 2013
Last Update Posted: February 13, 2015
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.
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc.
  Purpose
  1. To develop a database containing matched information from dynamic tests of postprandial glycemic control (OGTT or MMTT), results of a broad panel of fasting biomarkers, and clinical information related to diabetes risk obtain through subject interview.
  2. To use the database to identify fasting biomarkers and associated algorithms to best predict parameters derived from dynamic tests (OGTT or MMTT) such as Insulin Glucose Tolerance (IGT), impaired first phase insulin response, etc., controlling for clinical information such as current medication use.

Condition
Prediabetes Hypertension Obesity Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Fasting Biomarkers That Predict Responses to the Oral Glucose Tolerance Test (OGTT) and Mixed Meal Tolerance Test (MMTT)

Further study details as provided by Health Diagnostic Laboratory, Inc.:

Primary Outcome Measures:
  • Identify fasting biomarkers and associated algorithms to predict parameters [ Time Frame: Baseline ]
    To assess relations between baseline factors and patterns of change over time due to feeding treatments.


Biospecimen Retention:   Samples With DNA
Whole blood and serum

Estimated Enrollment: 1000
Study Start Date: August 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Representative of the ethnic population of Richmond, VA
Criteria

Inclusion Criteria:

  • Weight >95

Exclusion Criteria:

  • Prior diagnosis of Diabetes
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01998867


Locations
United States, Virginia
Health Diagnostic Laboratory, Inc.
Richmond, Virginia, United States, 23224
Sponsors and Collaborators
Health Diagnostic Laboratory, Inc.
Investigators
Principal Investigator: Szilard Voros, MD Health Diagnostic Laboratory, Inc.
  More Information

Publications:

Responsible Party: Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier: NCT01998867     History of Changes
Other Study ID Numbers: R2013-1003
First Submitted: November 25, 2013
First Posted: December 2, 2013
Last Update Posted: February 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases