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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01573949
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Heart Failure	Drug: Metformin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Left Ventricular Ejection Fraction (LVEF) [3 months]

   Obtained from Echocardiography

3. Creatinine Level as a Measure of Renal Function [3 months]

   Serum creatinine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmanson-UCLA Cardiomyopathy Center	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Tamara Horwich, MD, MS, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tamara Horwich, Tamara Horwich, MD, MS, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01573949
• Other Study ID Numbers: 11-002909
• First Posted: Apr 10, 2012
• Last Update Posted: Sep 4, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Tamara Horwich, Tamara Horwich, MD, MS, University of California, Los Angeles: 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
• Additional relevant MeSH terms: Heart Failure; Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Metformin

Study Results

Participant Flow

Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (8)
Sex: Female, Male (Count of Participants)
Female	1 14.3%
Male	6 85.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Health-Related Quality of Life (HRQoL)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Measure Participants	7
Baseline	37
Three Months	37

2. Secondary Outcome

Title	Glycated Hemoglobin (HbA1c)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Measure Participants	7
Baseline	6.1 (0.4)
Three Months	6.2 (0.4)

3. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Obtained from Echocardiography
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Measure Participants	7
Baseline	25 (8)
Three Months	26 (9)

4. Secondary Outcome

Title	Creatinine Level as a Measure of Renal Function
Description	Serum creatinine
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Measure Participants	7
Baseline	1.1 (0.2)
Three Months	1.1 (0.2)

Adverse Events

Time Frame	3 months
Arm/Group Title	Metformin
Arm/Group Description	Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
All Cause Mortality
	Metformin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Metformin
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Metformin
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.