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Completed

NCT Number: NCT01573949

A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)

The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will assess the use of the medication metformin to improve quality of life, exercise capacity, and improved outcomes in heart failure patients with pre-DM or early DM (type II).

If the patient participates in this study, the patient will receive the drug metformin for approximately 3 months. During the study the patient will undergo comprehensive testing which includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The patient must be 18 years old to participate.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmanson-UCLA Cardiomyopathy Center

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic HF of any etiology
  • age ≥ 18 years
  • fasting blood sugar equal or greater than 100 mg/dL, or pre-DM (HbA1c 5.7 - 6.4%) or early DM (HbA1c ≥ 6.5%)

Exclusion criteria

  • current metformin therapy or other anti-diabetic therapy
  • previous intolerance to metformin therapy
  • renal dysfunction (Cr >1.5 in men or > 1.4 in women or creatinine clearance < 60 ml/minute)
  • history of lactic acidosis
  • current or planned pregnancy or breast-feeding

Treatment and study plan

metformin

Drug

Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month for a duration of 3 months.

Primary outcomes

  1. Health-Related Quality of Life (HRQoL)

    Time frame: 3 months

    HRQoL as assessed by the Minnesota Living With Heart Failure Questionnaire (MLHFQ)

    The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score range 0-105. Lower scores indicate better health-related quality of life (HRQoL).

Secondary outcomes

  1. Glycated Hemoglobin (HbA1c)

    Time frame: 3 months

    The HbA1c test measures how much glucose is bound to hemoglobin in the red blood cells. The test shows the average level of glucose in blood for the past 3 months (the average lifespan of red blood cells). If glucose levels have been high over recent weeks, the hemoglobin A1c test will be higher.

  2. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 3 months

    Obtained from Echocardiography

  3. Creatinine Level as a Measure of Renal Function

    Time frame: 3 months

    Serum creatinine

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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