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

Not Applicable

Completed

• Conditions: Diabetes; Heart Failure
• Interventions: Drug: Metformin

• Registration Number: NCT01573949
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2020-08
• Results First Submitted: 2020-08-20
• Results First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Results First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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%)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Creatinine Level as a Measure of Renal Function	3 months	Serum creatinine
Left Ventricular Ejection Fraction (LVEF)	3 months	Obtained from Echocardiography

Trial Locations

Locations (1)

Ahmanson-UCLA Cardiomyopathy Center; 🇺🇸 Los Angeles, California, United States