Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.
Primary Aim Among adult individuals with type 2 diabetes mellitus (T2DM) and at risk for diastolic heart failure (DHF) and mildly reduced renal filtration function (Type 4 cardiorenal syndrome), to evaluate the quantitative impact on the MISS (myocardial injury summary score) cardiac biomarker score, cardiac fibrosis by MRI, cardiac strain by ultrasonography and strain rate imaging, and KISS (kidney injury summary score) kidney biomarker score after 38 weeks of treatment with exenatide extended-release or placebo. Secondary Aim To evaluate the inter-relationships between demographic, clinical, and biochemical variables (MISS score, KISS score) and of progressive cardiac fibrosis as assessed by MRI, strain-rate imaging, and in adult individuals with T2DM and at risk for DHF (Type 4 cardiorenal syndrome).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Galectin-3
Mean change in plasma galectin-3 (pg/ml)
Time frame: 38 weeks
ST2
Mean change in plasma ST2 (pg/ml)
Time frame: 38 weeks
NGAL
Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio
Time frame: 38 weeks
KIM-1
Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio
Time frame: 38 weeks
L-FABP
Mean change in urine L-type fatty acid binding protein:Cr ratio
Time frame: 38 weeks
IL-18
Mean change in urine interleukin-18:Cr ratio
Time frame: 38 weeks
Alpha GST
Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio
Time frame: 38 weeks
Troponin I
Mean change in plasma ultrasensitive troponin I (pg/ml)
Time frame: 38 weeks
Pi GST
Mean change in pi glutathione S-transferase (piGST):Cr ratio
Time frame: 38 weeks
NAG
Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio
Time frame: 38 weeks
Cystatin-C
Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)
Time frame: 38 weeks
BNP
Mean change in plasma B-type natriuretic peptide BNP (pg/ml)
Time frame: 38 weeks
ACR
Mean change in urine albumin:Cr ratio (ACR)
Time frame: 38 weeks
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