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Investigating the roles of hyperglycaemia, hyperinsulinaemia and elevated free fatty acids in cardiac function in patients with type 2 diabetes via treatment with insulin compared with empagliflozin: protocol for the HyperCarD2 randomised, crossover trial.
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- Author(s): Thirumathyam R;Thirumathyam R; Richter EA; Richter EA; Goetze JP; Goetze JP; Fenger M; Fenger M; Van Hall G; Van Hall G; Van Hall G; Dixen U; Dixen U; Holst JJ; Holst JJ; Holst JJ; Madsbad S; Madsbad S; Vejlstrup N; Vejlstrup N; Madsen PL; Madsen PL; Jørgensen NB; Jørgensen NB
- Source:
BMJ open [BMJ Open] 2022 Aug 11; Vol. 12 (8), pp. e054100. Date of Electronic Publication: 2022 Aug 11.- Publication Type:
Clinical Trial Protocol; Journal Article- Language:
English - Source:
- Additional Information
- Source: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
- Publication Information: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
- Subject Terms: Cardiovascular Diseases* ; Diabetes Mellitus, Type 2*/complications ; Diabetes Mellitus, Type 2*/drug therapy ; Hyperglycemia* ; Hyperinsulinism* ; Sodium-Glucose Transporter 2 Inhibitors*/therapeutic use; Benzhydryl Compounds/therapeutic use ; Cross-Over Studies ; Fatty Acids, Nonesterified ; Glucose ; Glucosides ; Humans ; Hypoglycemic Agents/therapeutic use ; Insulin/therapeutic use ; Randomized Controlled Trials as Topic ; Stroke Volume ; Ventricular Function, Left
- Abstract: Introduction: Type 2 diabetes (T2D) is characterised by elevated plasma glucose, free fatty acid (FFA) and insulin concentrations, and this metabolic profile is linked to diabetic cardiomyopathy, a diastolic dysfunction at first and increased cardiovascular disease (CVD) risk. Shifting cardiac metabolism towards glucose utilisation has been suggested to improve cardiovascular function and CVD risk, but insulin treatment increases overall glucose oxidation and lowers lipid oxidation, without reducing CVD risk, whereas SGLT2 inhibitors (SGLT2i) increase FFA, ketone body concentrations and lipid oxidation, while decreasing insulin concentrations and CVD risk. The aim of the present study is to elucidate the importance of different metabolic profiles obtained during treatment with a SGLT2i versus insulin for myocardial function in patients with T2D.
Methods and Analyses: Randomised, crossover study, where 20 patients with T2D and body mass index>28 kg/m 2 receive 25 mg empagliflozin daily or NPH insulin two times per day first for 5 weeks followed by a 3-week washout before crossing over to the remaining treatment. Insulin treatment is titrated to achieve similar glycaemic control as with empagliflozin. In those randomised to insulin first, glycaemia during an initial empagliflozin run-in period prior to randomisation serves as target glucose. Metabolic and cardiac evaluation is performed before and at the end of each treatment period.The primary endpoint is change (treatment-washout) in left ventricular peak filling rate, as assessed by cardiac MRI with and without acute lowering of plasma FFAs with acipimox. Secondary and explorative endpoints are changes in left atrial passive emptying fraction, left ventricular ejection fraction, central blood volume and metabolic parameters.
Ethics and Dissemination: This study is approved by the Danish Medicines Agency (ref. nr.: 2017061587), the Danish Data Protection Agency (ref. nr.: AHH-2017-093) and the Capital Region Ethics Committee (ref. nr.: H-17018846). The trial will be conducted in accordance with ICH-GCP guidelines and the Declaration of Helsinki and all participants will provide oral and written informed consent. Our results, regardless of outcome, will be published in relevant scientific journals and we also will seek to disseminate results through presentations at scientific meetings.
Trial Registration Number: EudraCT: 2017-002101.
Competing Interests: Competing interests: SM and NBJ have received research grants from Boehringer Ingelheim and JJH serves on advisory boards for Novo Nordisk.
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ESC Heart Fail. 2020 Sep 18;:. (PMID: 32946200) - Contributed Indexing: Keywords: coronary heart disease; diabetes & endocrinology; diabetic nephropathy & vascular disease; ischaemic heart disease; myocardial infarction
- Accession Number: 0 (Benzhydryl Compounds)
0 (Fatty Acids, Nonesterified)
0 (Glucosides)
0 (Hypoglycemic Agents)
0 (Insulin)
0 (Sodium-Glucose Transporter 2 Inhibitors)
HDC1R2M35U (empagliflozin)
IY9XDZ35W2 (Glucose) - Publication Date: Date Created: 20220811 Date Completed: 20220815 Latest Revision: 20220831
- Publication Date: 20221213
- Accession Number: PMC9379482
- Accession Number: 10.1136/bmjopen-2021-054100
- Accession Number: 35953245
- Source:
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