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

NCT ID: NCT01573949

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-12-31

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.

Conditions

Diabetes; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Tamara Horwich

Tamara Horwich, MD, MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara Horwich, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Ahmanson-UCLA Cardiomyopathy Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

11-002909

Identifier Type: -

Identifier Source: org_study_id