Prospective single-center case-control proof of principle study to determine the association of glucagon-mediated activation of the calcineurin-pathway with left ventricular hypertrophy in insulin-resistant diabetic patients

Prospective single-center case-control *proof of principle* study to determine the association of glucagon-mediated activation of the calcineurin-pathway with left ventricular hypertrophy in insulin-resistant diabetic patients - LVH-DM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36906

Enrollment

Registered

2012-12-10

Start date

2013-05-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

left ventricular hypertrophy thickening of the muscle of the heart

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient is * 18 years-old. 2. Insulin-resistance requiring insulin injection of more than 1,5 IU/kg/day 3. Written informed consent to participate in this study prior to any study procedures

Exclusion criteria

Exclusion criteria: 1. Any (known) cardiac history 2. Patients treated with any dose of glucagon-lowering medication as DPP-4 inhibitors (Saxagliptin, Sitagliptin and Vildagliptin) and incretin-mimetics (Exenatide and Liraglutide). 3. Patients treated with immunosuppressive medication as cyclosporine A, tacrolimus or pimecrolimus. 4. Patients with current uncontrolled hypertension or uncontrolled hypertension in the past two years (Office measurement of systolic blood pressure >165 mmHg or office diastolic blood pressure >105 mmHg at any moment in the past two years) 5. Presence of any cardiac abnormalities on study-related echocardiographic examination (clinically relevant valvular disease, severe congenital abnormalities, asymmetric hypertrophy with one wall exceeding 15mm while other areas are below 10mm thickness, dilated cardiomyopathies) 6. Patients with contraindications for MRI or gadolinium contrast (claustrophobia, implanted electronic devices, creatinine > 200 µmol/L determined within 3 months prior to inclusion, proven gadolinium contrast allergy) 7. Presence of a glucagonoma

Design outcomes

Primary

Measure	Time frame
Primary endpoint of this investigation will be a significant (P	—

Secondary

Measure	Time frame
Secondary endpoint will be a significant (P	—

Countries

Netherlands

Outcome results