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

NCT01573949 | Completed Results

• 1 other identifier: 11-002909
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Secondary Outcomes (3)

• Glycated Hemoglobin (HbA1c)

  3 months

• Left Ventricular Ejection Fraction (LVEF)

  3 months

• Creatinine Level as a Measure of Renal Function

  3 months

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.

Drug: Metformin

Interventions

Metformin 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.

Metformin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ahmanson-UCLA Cardiomyopathy Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure; Glucose Intolerance; Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Tamara Horwich, MD, MS
• Organization: University of California Los Angeles

thorwich@mednet.ucla.edu

310-825-8816

Study Officials

• Tamara Horwich, MD, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tamara Horwich, MD, MS

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 10, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Locations

US (1)