Dataset Information

Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.

ABSTRACT:

Background

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide may be beneficial in the regression of diabetic cardiomyopathy. South Asian ethnic groups in particular are at risk of developing type 2 diabetes.

Purpose

To assess the effects of liraglutide on left ventricular (LV) diastolic and systolic function in South Asian type 2 diabetes patients.

Study type

Prospective, double-blind, randomized, placebo-controlled trial.

Population

Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease, who were randomly assigned to 26-week treatment with liraglutide (1.8 mg/day) or placebo.

Field strength/sequence

3T (balanced steady-state free precession cine MRI, 2D and 4D velocity-encoded MRI, ¹ H-MRS, T₁ mapping).

Assessment

Primary endpoints were changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction). Secondary endpoints were changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV]).

Statistical tests

Data were analyzed according to intention-to-treat. Between-group differences were reported as mean (95% confidence interval [CI]) and were assessed using analysis of covariance (ANCOVA).

Results

Liraglutide (n = 22) compared with placebo (n = 25) did not change Edec (+0.2 mL/s² × 10^-3 (-0.3;0.6)), E/A (-0.09 (-0.23;0.05)), E/Ea (+0.1 (-1.2;1.3)) and ejection fraction (0% (-3;2)), but decreased stroke volume (-9 mL (-14;-5)) and increased heart rate (+10 bpm (4;15)). Aortic PWV (+0.5 m/s (-0.6;1.6)), myocardial triglyceride content (+0.21% (-0.09;0.51)), and ECV (-0.2% (-1.4;1.0)) were unaltered.

Data conclusion

Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease.

Level of evidence

1 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;51:1679-1688.

SUBMITTER: Paiman EHM

PROVIDER: S-EPMC7318583 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.

Paiman Elisabeth H M EHM van Eyk Huub J HJ van Aalst Minke M A MMA Bizino Maurice B MB van der Geest Rob J RJ Westenberg Jos J M JJM Geelhoed-Duijvestijn Petronella H PH Kharagjitsingh Aan V AV Rensen Patrick C N PCN Smit Johannes W A JWA Jazet Ingrid M IM Lamb Hildo J HJ

Journal of magnetic resonance imaging : JMRI 20191204 6

<h4>Background</h4>The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide may be beneficial in the regression of diabetic cardiomyopathy. South Asian ethnic groups in particular are at risk of developing type 2 diabetes.<h4>Purpose</h4>To assess the effects of liraglutide on left ventricular (LV) diastolic and systolic function in South Asian type 2 diabetes patients.<h4>Study type</h4>Prospective, double-blind, randomized, placebo-controlled trial.<h4>Population</h4>Forty-seven type 2 ...[more]

PMID: 31799782

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Project description:BackgroundSouth Asians have a high risk to develop type 2 diabetes, which may be related to substantial ectopic fat deposition. Since glucagon-like peptide-1 analogues can reduce ectopic fat accumulation, the aim of the present study was to assess the effect of treatment with liraglutide for 26 weeks on ectopic fat deposition and HbA1c in South Asian patients with type 2 diabetes.MethodsIn a placebo-controlled trial, 47 South Asian patients with type 2 diabetes were randomly assigned to treatment with liraglutide (1.8 mg/day) or placebo added to standard care. At baseline and after 26 weeks of treatment we assessed abdominal subcutaneous, visceral, epicardial and paracardial adipose tissue volume using MRI. Furthermore, myocardial and hepatic triglyceride content were examined with proton magnetic resonance spectroscopy.ResultsIn the intention-to-treat analysis, liraglutide decreased body weight compared to placebo (- 3.9 ± 3.6 kg vs - 0.6 ± 2.2 kg; mean change from baseline (liraglutide vs placebo): - 3.5 kg; 95% CI [- 5.3, - 1.8]) without significant effects on the different adipose tissue compartments. HbA1c was decreased in both groups without between group differences. In the per-protocol analysis, liraglutide did decrease visceral adipose tissue volume compared to placebo (- 23 ± 27 cm2 vs - 2 ± 17 cm2; mean change from baseline (liraglutide vs placebo): - 17 cm2; 95% CI [- 32, - 3]). Furthermore, HbA1c was decreased by liraglutide compared to placebo (- 1.0 ± 0.8% (- 10.5 ± 9.1 mmol/mol)) vs (- 0.6 ± 0.8% (- 6.1 ± 8.8 mmol/mol)), with a between group difference (mean change from baseline (liraglutide vs placebo): - 0.6% (- 6.5 mmol/mol); 95% CI [- 1.1, - 0.1 (- 11.5, - 1.5)]). Interestingly, the decrease of visceral adipose tissue volume was associated with the reduction of HbA1c (β: 0.165 mmol/mol (0.015%) per 1 cm2 decrease of visceral adipose tissue volume; 95% CI [0.062, 0.267 (0.006, 0.024%)]).ConclusionsWhile the intention-to-treat analysis did not show effects of liraglutide on ectopic fat and HbA1c, per-protocol analysis showed that liraglutide decreases visceral adipose tissue volume, which was associated with improved glycaemic control in South Asians. Trial registration NCT02660047 (clinicaltrials.gov). Registered 21 January 2016.

Project description:BackgroundGlucagon-like peptide-1 receptor (GLP-1R) activation may improve myocardial performance in the context of ischaemia, independent of glycaemic control, in individuals with and without type 2 diabetes mellitus.MethodsThe LIONESS trial was a single-centre randomised double-blind placebo-controlled crossover study to determine whether prolonged GLP-1R activation could improve exercise haemodynamics in chronic stable angina patients. Eligibility criteria comprised angiographic evidence of obstructive coronary artery disease (CAD) and an abnormal baseline exercise tolerance test (ETT) demonstrating > 0.1 mV of planar or downsloping ST-segment depression (STD). Those randomised to active agent started with a 1-week run-in phase of 0.6 mg liraglutide daily, an established injectable GLP-1R agonist, followed by 1 week of 1.2 mg liraglutide, after which patients performed a week 2 ETT. Patients then self-administered 1.8 mg liraglutide for a week before completing a week 3 ETT. The placebo arm received visually and temporally matched daily saline injections. Participants then crossed over to a 3-week course of saline injections interspersed with a week 5 ETT and week 6 ETT and vice versa. Co-primary endpoints were rate pressure product (RPP) at 0.1 mV STD and magnitude of STD at peak exercise.ResultsTwenty-two patients (21 without diabetes) were randomised. There was no significant difference between saline versus liraglutide in the co-primary endpoints of RPP achieved at 0.1 mV STD (saline vs. liraglutide 1.2 mg p = 0.097; saline vs. liraglutide 1.8 mg p = 0.48) or the degree of STD at peak exercise (saline vs. liraglutide 1.2 mg p = 0.68; saline vs. liraglutide 1.8 mg p = 0.57). Liraglutide did not cause symptomatic hypoglycaemia, renal dysfunction, acute pancreatitis or provoke early withdrawal from the trial. Liraglutide significantly reduced weight (baseline 88.75 ± 16.5 kg vs. after liraglutide 87.78 ± 16.9 kg; p = 0.0008) and improved the lipid profile (mean total cholesterol: at baseline 3.97 ± 0.88 vs. after liraglutide 3.56 ± 0.71 mmol/L; p < 0.0001).ConclusionLiraglutide did not enhance exercise tolerance or haemodynamics compared with saline placebo during serial treadmill testing in patients with established obstructive CAD. It did, however, significantly reduce weight and improve the lipid profile. Trial Registration ClinicalTrials.gov Identifier NCT02315001. Retrospectively registered on 11th December 2014.

Project description:BackgroundType 2 diabetes (T2D) disproportionately affects individuals of South Asian descent. Additionally, diabetes distress (DD) may lead to complications with diabetes management. This study examines the prevalence of DD among foreign-born individuals of South Asian descent in New York City (NYC) and its association with sociodemographic and clinical factors.MethodsBaseline data was collected from the Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, an intervention designed to reduce hemoglobin A1c (HbA1c) among South Asian individuals with uncontrolled T2D at primary care practices in NYC. The Diabetes Distress Scale (DDS) measured DD, and Core Healthy Days Measures assessed physical and mental healthy days. Sociodemographic variables were analyzed using descriptive statistics, Chi-square tests assessed categorical variables, and Wilcoxon Rank Sum tests evaluated continuous variables (Type I error rate = 0.05). Logistic regression models examined associations between HbA1c, mental health, and other covariates with dichotomized DD subscales.ResultsOverall, 414 participants completed the DDS at baseline (median age = 55.2 years; SD = 9.8). All were born outside of the US; the majority were born in Bangladesh (69.8%) followed by India, Pakistan, and Nepal (24.7%) and Guyana and Trinidad and Tobago (5.5%). High emotional burden, regimen-related distress and physician-related distress were reported by 25.9%, 21.9%, and 6.2% of participants, respectively. In adjusted analyses, individuals with ≥ 1 day of poor mental health had higher odds of overall distress (OR:3.8, p = 0.013), emotional burden (OR:4.5, p < 0.001), and physician-related distress (OR:4.6, p = 0.007) compared to individuals with no days of poor mental health. Higher HbA1c (OR:1.45, p = < 0.001) was associated with regimen-related distress; and lower emotional support was associated with overall distress (OR:0.92, p < 0.001) and regimen-related distress (OR:0.95, p = 0.012). Individuals born in Bangladesh had significantly lower odds of overall distress, emotional burden, and regimen-related distress compared to individuals born in Guyana and Trinidad and Tobago.ConclusionsFindings highlight the rate and risk factors of DD among individuals of South Asian descent living in NYC. Screening for DD in patients with prediabetes or diabetes should be integrated to address mental and physical health needs. Future research can benefit from a longitudinal analysis of the impact of DD on diabetes self-management and health outcomes.Trial registrationThis study uses baseline data from "Diabetes Management Intervention for South Asians" (NCT03333044), which was registered with clinicaltrials.gov on 6/11/2017.

Project description:BackgroundConversional bariatric surgery inherently has less weight loss (WL) compared to primary procedures. Adjunctive use of the GLP-1 analog, liraglutide with conversional Roux-en-Y Gastric Bypass (cRYGB) may maximize the WL benefits of surgery.Material and methodsThis single-center randomized double-blind placebo-controlled trial included 80 patients randomized into two groups; the liraglutide group (40 patients) who received daily injections of liraglutide, and the placebo group (40 patients) who received normal saline starting at 6 weeks from cRYGB and continued for 6 months. After discontinuing the drugs at 6 months and unblinding, the patient were followed up to 12 months. The endpoints were percentage of total weight loss (%TWL) and percentage of excess weight loss (%EWL), and changes in the metabolic biomarkers, and complications within 30 and 90 days according to the global outcome benchmark (GOB) stratification.ResultsIn total, 38 patients in the liraglutide group and 31 in the placebo group completed the 24 weeks. Liraglutide group experienced better WL with a significantly higher mean %TWL at 1 month (10.27±1.39 vs. 8.41±2.08), at 6 weeks (12.65±1.77 vs. 10.47±2.23), at 6 months (18.29 ±1.74 vs. 15.58 ±1.65), and at 12 months 24.15±2.35 versus 22.70±2.13 (all P <0.001). For %EWL, this was also significantly higher in the liraglutide group at all time points. A %TWL of greater than 20% at 6 months of treatment was recorded in six (15.8%) patients in the liraglutide group and none in the placebo group ( P =0.029). Both groups had comparable changes in metabolic biomarkers. Adverse events were recorded in 11 (27.5%) patients in the liraglutide, with no adverse events in the placebo group ( P <0.001). Both groups had Clavien-Dindo scores I and II (5.0 and 2.5%), and GOB values indicated that 90.0 and 97.5% were low-risk patients.ConclusionAdjunctive use of liraglutide with cRYGB gives significantly higher WL and resolution of associated medical problems.

Dataset Information

Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.

Background

Purpose

Study type

Population

Field strength/sequence

Assessment

Statistical tests

Results

Data conclusion

Level of evidence

Publications

Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.

Similar Datasets

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