Fasting Predictors of OGTT and MMTT Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Health Diagnostic Laboratory, Inc.
Sponsor:
Information provided by (Responsible Party):
Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier:
NCT01998867
First received: November 25, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01998867

Contacts
Contact: Stephen Varvel, PhD 804-343-2718 ext 2231 svarvel@hdlabinc.com
Contact: Monique Alston, LPN 804-343-2718 ext 2210 malston@hdlabinc.com

Locations
United States, Virginia
Health Diagnostic Laboratory, Inc. Recruiting
Richmond, Virginia, United States, 23224
Contact: Monique Alston, LPN    804-343-2718 ext 2210    malston@hdlabinc.com   
Contact: Stephen Varvel, PhD    804-836-4439    svarvel@hdlabinc.com   
Principal Investigator: Szilard Voros, MD         
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
Study First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Obesity
Glucose Intolerance
Prediabetic State
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014