Understanding the Effect of Metformin on Corus CAD (or ASGES) (MET)

January 29, 2019 updated by: CardioDx

Understanding the Effect of Metformin on Corus CAD (MET Study)

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD (henceforth "Corus") in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. The primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type II diabetes had a significant effect on the gene expression levels measured in Corus. This was a prospective study. Subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. The study aimed to enroll approximately fifty (50) patients.

Study Type

Observational

Enrollment (Actual)

37

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from participating sites as applicable inclusion/exclusion criteria are met. The study aims to enroll approximately fifty (50) patients.

Description

Inclusion Criteria:

At least 21 years of age

Any of the following:

  • Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
  • Low-risk unstable angina, or
  • Asymptomatic individuals with a high probability of CAD

Clinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:

  • HgA1C: >5.7% - <6.4%,
  • BMI> 35 kg/m2
  • Age< 60 yrs
  • Prior Gestational Diabetes Mellitus
  • FPG: >100mg/dl - <126mg/dl
  • OGTT: >140mg/dl - <200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent

Exclusion Criteria:

  • History of or current level of HbA1C >6.5
  • History of or current prescription of metformin or any other diabetic medication
  • History of myocardial infarction (MI) or prior revascularization
  • Current MI or acute coronary syndrome (ACS)
  • Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  • Current systemic infectious or systemic inflammatory conditions
  • Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Corus CAD (ASGES) Post-metformin
Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient).
Diagnostic test: Corus CAD (ASGES)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metformin effect on Corus CAD
Time Frame: 7 days (+7days)
Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results
7 days (+7days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioDx

Investigators

  • Principal Investigator: Mark Mouton, MD, The Mouton Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX_000018
  • MET Study (Other Identifier: CardioDx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on Corus CAD (ASGES)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe