The effect of exenatide compared to insulin glargine on cardiac function and metabolism in type 2 diabetic patients with congestive heart failure: a randomized-controlled trial

Phase 4

Completed

Conditions: Diabetic cardiomyopathy
diabetic heart failure
10019280
10018424

Registration Number: NL-OMON35173

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

- Patients:
Type 2 diabetic patients
Male and postmenopausal female
Age 18 years and above
Metformin therapy (stable, maximum tolerable dose for 2 months)
HbA1c 6.5-10%
Confirmed congestive heart failure (NYHA, functional class II-IV)
Ejection Fraction (EF)<50%
Stable standard therapy for their cardiac condition for 3 months prior to entering the study;- Healthy controls:
Male and postmenopausal female
Age 18 years and above
No known acute or chronic disease

Exclusion Criteria

- Patients:
Type 1 diabetes
Serious renal (creatinine clearance< 50 ml/min) or liver impairment
(Receiving treatment for) malignant disease
Cardiovascular event< 3 months prior to inclusion
Acute congestive heart failure
Any reason for not being able to sustain the imaging studies (impairment to understand the aim of the study/procedures, implanted devices, claustrophobia, atrial fibrillation, orthopnoe)
Contraindications for the use of exenatide/insulin
Use of insulin, thiazolidiones, (other than study) incretin-based therapies within 4 months of screening
Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (>2 weeks) within 2 weeks immediately prior to screening;- Healthy controls:
Chronic use of any drug
Impaired glucose tolerance (as assessed by a 75-g oral glucose tolerance test)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>I. what are the effects of 26-week exenatide compared to insulin glargine<br /><br>treatment in 42 patient with T2DM and CHF (NYHA II-IV) on global cardiac<br /><br>function, measured as ejection fraction (EF) using cardiac magnetic resonance<br /><br>(CMR). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>I. changes in regional intramural systolic and diastolic myocardial function<br /><br>assessed by CMR and strain analysis.<br /><br>II. cardiac oxygen consumption, cardiac efficiency and (stress) perfusion, as<br /><br>assessed by PET.<br /><br>III. patients* performance, measured by a 6-min. walk test and exercise<br /><br>capacity with VO2max test.</p><br>