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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|ClinicalTrials.gov Identifier: NCT01573949|
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
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.
- 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).
- 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.
- Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 3 months ]Obtained from Echocardiography
- Creatinine Level as a Measure of Renal Function [ Time Frame: 3 months ]Serum creatinine
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.
|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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%)
- 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
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
|United States, California|
|Ahmanson-UCLA Cardiomyopathy Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Tamara Horwich, MD, MS||University of California, Los Angeles|
|Responsible Party:||Tamara Horwich, Tamara Horwich, MD, MS, University of California, Los Angeles|
|Other Study ID Numbers:||
|First Posted:||April 10, 2012 Key Record Dates|
|Results First Posted:||September 4, 2020|
|Last Update Posted:||September 4, 2020|
|Last Verified:||August 2020|
Early type II diabetes
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
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs