NCT01043965

Brief Summary

The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries. Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_1 type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
Last Updated

January 7, 2010

Status Verified

August 1, 2005

Enrollment Period

4 years

First QC Date

January 6, 2010

Last Update Submit

January 6, 2010

Conditions

Type 2 Diabetes

Keywords

Diabetes MellitusMyocardial perfusion imagingHeart diseasesEchocardiographyEndothelium

Outcome Measures

Primary Outcomes (1)

  • myocardial blood flow velocity, myocardial blood flow reserve

    3 months

Study Arms (2)

Diabetes

ACTIVE COMPARATOR

Type 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin.

Drug: Metformin

Control

NO INTERVENTION

Control group - normal, healthy individuals.

Interventions

MetforminDRUG

Metformin 850mg

Also known as: Glucophage
Diabetes

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Normal echocardiogram
  • Absence of obstructive epicardial coronary disease

You may not qualify if:

  • Obstructive coronary disease
  • Heart valve disease
  • COPD
  • Cardiac Arrhythmias
  • Cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusHeart Diseases

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Wilson Mathias Jr, Md, PhD

    Heart Institute - Sao Paulo - Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

August 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 7, 2010

Record last verified: 2005-08