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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01573949
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Tamara Horwich, University of California, Los Angeles

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Heart Failure Drug: Metformin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin
Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
 Drug: Metformin
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573949


Locations
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United States, California
Ahmanson-UCLA Cardiomyopathy Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Tamara Horwich, MD, MS University of California, Los Angeles
More Information
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Responsible Party: Tamara Horwich, Tamara Horwich, MD, MS, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01573949    
Other Study ID Numbers: 11-002909
First Posted: April 10, 2012    Key Record Dates
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020
Last Verified: August 2020
Keywords provided by Tamara Horwich, University of California, Los Angeles:
Heart Failure
Diabetes
Pre-diabetes
 Early type II diabetes
Metformin
Pharmacotherapy with metformin for prevention of DM in HF patients with pre-diabetes (pre-DM) and glycemic control in HF patients with early type II DM
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Heart Diseases
Cardiovascular Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs