Diabetes, Heart Failure
Conditions
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
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.
Interventions
DRUGMetformin
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.
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life (HRQoL) | 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
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | 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) | 3 months | Obtained from Echocardiography |
| Creatinine Level as a Measure of Renal Function | 3 months | Serum creatinine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metformin Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Metformin | — |
|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 Participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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).
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Metformin | Health-Related Quality of Life (HRQoL) | Baseline | 37 score on a scale |
| Metformin | Health-Related Quality of Life (HRQoL) | Three Months | 37 score on a scale |
Secondary
Creatinine Level as a Measure of Renal Function
Serum creatinine
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin | Creatinine Level as a Measure of Renal Function | Baseline | 1.1 mg/dL | Standard Deviation 0.2 |
| Metformin | Creatinine Level as a Measure of Renal Function | Three Months | 1.1 mg/dL | Standard Deviation 0.2 |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin | Glycated Hemoglobin (HbA1c) | Baseline | 6.1 percentage of glycated hemoglobin | Standard Deviation 0.4 |
| Metformin | Glycated Hemoglobin (HbA1c) | Three Months | 6.2 percentage of glycated hemoglobin | Standard Deviation 0.4 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Obtained from Echocardiography
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metformin | Left Ventricular Ejection Fraction (LVEF) | Baseline | 25 percent ejection fraction | Standard Deviation 8 |
| Metformin | Left Ventricular Ejection Fraction (LVEF) | Three Months | 26 percent ejection fraction | Standard Deviation 9 |