Fasting Predictors of OGTT and MMTT Response
Sponsor
Health Diagnostic Laboratory, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01998867
Collaborator
(none)
1,000
1
60
16.7
Study Details
Study Description
Brief Summary
-
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.
-
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
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)
Study Start Date
:
Aug 1, 2013
Anticipated Primary Completion Date
:
Aug 1, 2018
Anticipated Study Completion Date
:
Aug 1, 2018
Outcome Measures
Primary Outcome Measures
- Identify fasting biomarkers and associated algorithms to predict parameters [Baseline]
To assess relations between baseline factors and patterns of change over time due to feeding treatments.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Weight >95
Exclusion Criteria:
- Prior diagnosis of Diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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.
Study Documents (Full-Text)
None provided.More Information
Publications
- DeFronzo RA, Abdul-Ghani M. Type 2 diabetes can be prevented with early pharmacological intervention. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S202-9. doi: 10.2337/dc11-s221.
- Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available.
- Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Pratley R, Zinman B; American Diabetes Association. Impaired fasting glucose and impaired glucose tolerance: implications for care. Diabetes Care. 2007 Mar;30(3):753-9. doi: 10.2337/dc07-9920. No abstract available.
- Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1001.
Responsible Party:
Health Diagnostic Laboratory, Inc.
ClinicalTrials.gov Identifier:
NCT01998867
Other Study ID Numbers:
- R2013-1003
First Posted:
Dec 2, 2013
Last Update Posted:
Feb 13, 2015
Last Verified:
Feb 1, 2015
Additional relevant MeSH terms: