THE ROLE OF HYPERGLYCEMIA, HYPERINSULINEMIA AND ELEVATED FREE FATTY ACIDS FOR CARDIAC FUNCTION IN PATIENTS WITH TYPE 2 DIABETES

Phase 1

• Conditions: typé 2 diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-002101-35-DK
• Lead Sponsor: Sten Madsbad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-21
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Elegible for inclusion are male patients aged =18 years with T2DM who are either drug naïve (no anti-diabetes agents for =12 weeks prior to randomization) with HbA1c =10.0% or taking any background anti-diabetes therapy (except insulin) with HbA1c =9.0% despite diet and exercise counseling.
6.1 INCLUSION CRITERIA:
•Age = 18 years
•BMI = 28 kg/m2
•HbA1c = 9.0% (=10% in diet or metformin only treated patients)
•Fasting C-peptide = 500 pmol/L
•Unchanged antiglycemic treatment 12 weeks prior to inclusion as assessed by investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

EXCLUSION CRITERIA:
•Insulin treatment within 3 months of informed consent
•Type 1 diabetes
•Psychiatric disorder or mental retardation
•Drug or alcohol abuse within 3 months from informed consent
•Poor compliance
•Anemia (hgb = 6.4 mmol/L) or other blood dyscrasias causing hemolysis or unstable red blood cells
•Indication of liver disease, defined by serum levels of alanine amininotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit
•Impaired renal function (eGFR<45ml/min/1.73 m2)
•Treatment with anti-obesity drugs 3 months prior to informed consent
•Systemic steroid treatment within 6 weeks of informed consent
•Uncontrolled thyroid disease (prescribed changes in thyroid medication within the 6 weeks prior to informed consent)
•Any uncontrolled endocrine disorder except type 2 diabetes
•Bariatric surgery or other gastrointestinal disorders that compromises gastrointestinal absorption
•Peptic ulcer – verified by endoscopically
•Any form of planned surgery within 3 months of informed consent
•Acute coronary syndrome, stroke or TCI within 2 months prior to informed consent
•Persistent atrial fibrillation
•Inability to undergo experimental procedures including exclusion criteria for MRI scanning:
oImplantable cardioverter defibrillator/pacemaker
oFerromagnetic clips
oClaustrophobia.
•Contraindication to glycopyrrolate infusion:
oKnown closed-angle glaucoma
oknown severe prostate hyperplasia
oTachycardia (HR > 100 at rest)
oKnown bladder atony
oCardia insufficiency or non-congenital pylorus stenosis – verified endoscopically
oKnown gastroparesis
•Allergy towards any of the drugs or diagnostics used in the protocol (insulin, empagliflozin, acipimox, glycopyrrolate, adenosine, gadolinium contrast enhancer).
•Any condition which in the opinion of the investigator may jeopardize subject safety or compliance with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified