Back to resultsA Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Primary Purpose
Diabetes, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring 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
Eligibility 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
Sites / Locations
- Ahmanson-UCLA Cardiomyopathy Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metformin
Arm Description
Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
Outcomes
Primary Outcome Measures
Health-Related Quality of Life (HRQoL)
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
Glycated Hemoglobin (HbA1c)
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.
Left Ventricular Ejection Fraction (LVEF)
Obtained from Echocardiography
Creatinine Level as a Measure of Renal Function
Serum creatinine
Full Information
NCT ID
NCT01573949
First Posted
March 29, 2012
Last Updated
August 20, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01573949
Brief Title
A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Official Title
A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Heart Failure
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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 Outcome Measure Information:
Title
Health-Related Quality of Life (HRQoL)
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Glycated Hemoglobin (HbA1c)
Description
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.
Time Frame
3 months
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Obtained from Echocardiography
Time Frame
3 months
Title
Creatinine Level as a Measure of Renal Function
Description
Serum creatinine
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Horwich, MD, MS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmanson-UCLA Cardiomyopathy Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
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