Fasting Predictors of OGTT and MMTT Response

Obesity Clinical Trial

Official title:

Identification of Fasting Biomarkers That Predict Responses to the Oral Glucose Tolerance Test (OGTT) and Mixed Meal Tolerance Test (MMTT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01998867
• Other study ID #: R2013-1003
• Status: Active, not recruiting
• Phase: N/A
• First received: November 25, 2013
• Last updated: February 12, 2015
• Start date: August 2013
• Est. completion date: August 2018

Study information

• Verified date: February 2015
• Source: Health Diagnostic Laboratory, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Weight >95

Exclusion Criteria:

• Prior diagnosis of Diabetes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension
• Obesity
• Prediabetes

Locations

Country	Name	City	State
United States	Health Diagnostic Laboratory, Inc.	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Health Diagnostic Laboratory, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

DeFronzo RA, Abdul-Ghani M. Type 2 diabetes can be prevented with early pharmacological intervention. Diabetes Care. 2011 May;34 Suppl 2:S202-9. doi: 10.2337/dc11-s221. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Circulation. 2012 Jun 5;125(22):e1001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify fasting biomarkers and associated algorithms to predict parameters	To assess relations between baseline factors and patterns of change over time due to feeding treatments.	Baseline	No