Clinical trial NCT00766857: Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
Official title: The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Congestive Heart Failure
Keywords: Exenatide
Type 2 diabetes mellitus
Congestive heart failure
Incretin hormones
GLP-1 agonist
Cardiac metabolism
Insulin resistance
Cardiac MRI
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if exenatide will improve global cardiac function in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects on cardiac metabolism leading to improvement of cardiac efficiency.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Male and postmenopausal female
* Age 18 years an above
* Metformin therapy (stable, maximum tolerable dose for 2 months)
* HbA1c 6.5-10%
* Confirmed congestive heart failure (NHYA functional class II-IV)
* Ejection fraction \< 50%
* Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study

Exclusion Criteria:

* Type 1 diabetes mellitus
* Serious renal 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
* Pacemaker/ICD
* Contraindications for the use of exenatide/ insulin
* Use of insulin, thiazolidinediones, 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

Primary outcomes:
measure: Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).
timeFrame: week -2 and week 11
Secondary outcomes:
measure: Cardiac oxygen consumption, cardiac efficiency and stress perfusion will be assessed by Positron Emission Tomography (PET) using 11C-acetate and H2-15O
timeFrame: week -2 and week 26
measure: Cardiac function, dimensions and scarring will be measured bij CMR
timeFrame: week -2 and week 26
measure: Myocardial diastolic function parameters will be obtained bij trans thoracal echocardiography. Comparisons will be made of strain and torsion measures obtained bij CMR and echocardiography.
timeFrame: week -2 and week 26
measure: Exercise capacity and performance will be assessed by a 6-minute walking test
timeFrame: week -1 and week 27
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord-Holland
Study officials:
affiliation: VUMC Diabetes Center
name: Michaela Diamant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen WJY, Diamant M, de Boer K, Harms HJ, Robbers LFHJ, van Rossum AC, Kramer MHH, Lammertsma AA, Knaapen P. Effects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine. Cardiovasc Diabetol. 2017 May 19;16(1):67. doi: 10.1186/s12933-017-0549-z.