MedDataX Logo

Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure

NCT ID: NCT00657280

Last Updated: 2014-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.

This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Screening:

Patients will be screened based on existing clinic information regarding NYHA class (New York Heart Association functional class) and heart failure characteristics. Patients will be approached in clinic after completing clinical care for that visit regarding participation in this trial.

If the patient agrees to participate, informed consent will be obtained at this time.

At enrollment:

Patients will be queried as to whether they have undergone previous nuclear medicine scans in the previous year in order to ensure that they do not exceed current standards for total annual radiation exposure.

Undergo a baseline combined 18-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/13N-NH3 PET/CT to assess the heart's ability to utilize blood sugar and coronary blood flow. This will take approximately 3-4 hours. This is a nuclear medicine procedure which is commonly used to assess myocardial viability as well as global heart function. It involves injection of a radioisotope-labeled tracers (18-FDG and 13N-NH3) intravenously followed by the measurement of myocardial uptake using a tomographic scanner. Venous blood samples performed during a 75g oral glucose load during the 18-FDG portion will assist with quantitation of myocardial glucose uptake and of measurements of insulin sensitivity. Perfusion (13N-NH3) images will be repeated during infusion of adenosine 0.14 mg/kg/min in order to assess coronary flow reserve. A computed tomography scan will be performed at the same time as the baseline PET scan for attenuation correction. Blood draws to measure changes in fasting insulin, blood sugar, lipid profile, and ADMA levels. Approximately 45 cc or 3 tablespoons of blood will be drawn and saved for possible future analysis.

18-FDG/13N-NH3 PET scans are routinely performed on patients with ischemic heart disease. While this study will use standard protocol for these examinations, they are not currently part of standard of care for nonischemic heart failure. However, they are important in testing the hypothesis of this study.

3\) Begin sitagliptin 100 mg daily for four weeks. If calculated creatinine clearance is 30-49 cc/min by the Cockcroft-Gault formula, sitagliptin dose will be reduced to 50 mg daily for four weeks as per manufacturer guidelines. There will be no placebo arm. This will be an open-label study. Patients will be advised regarding potential side effects to prompt notification of study personnel. They will be instructed to contact the investigators for any concerns or evidence of adverse effects.

4\) At four weeks: Repeat FDG/NH3 PET as above to compare to pretreatment scan. This will take approximately 3-4 hours. Blood draws to measure changes in fasting insulin, blood sugar, lipid profile, and ADMA (asymmetrical dimethylarginine) levels. Approximately 45 cc or 3 tablespoons of blood will be drawn and saved for possible future analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Congestive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All subjects recieve Sitagliptin

All subjects are aware of what they are taking. Nobody is blinded in this study. study

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

No one is blinded to the treatments.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sitagliptin

No one is blinded to the treatments.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Januvia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure
2. Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
3. Age \> 18 yrs

Exclusion Criteria

1. Cardiomyopathy primarily due to one of the following:

1. Ischemic heart disease
2. Primary valvular lesion
3. Hypertrophic cardiomyopathy
2. Cardiac resynchronization within the last 3 months
3. Calculated creatinine clearance \<30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockcroft-Gault formula.
4. Diagnosis of diabetes mellitus by:

1. Diabetes previously diagnosed per patient history
2. 2 or more fasting glucose values \> 125 mg/dl
5. History of heart transplantation
6. Pregnancy or active breast feeding
7. Hospitalization for decompensated heart failure within 30 days prior to enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Fowler

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael B Fowler

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Ronald M. Witteles MD

Role: STUDY_DIRECTOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SU-04082008-1088

Identifier Type: -

Identifier Source: org_study_id