The FibroCAN study

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Given informed consent

Type 2 diabetes defined by WHO criteria

Aged 40 ≥ at inclusion

Pathological E/I ratio (Mean value of three measures)

Exclusion Criteria

No CAN (no abnormal CARTs)

Server forms of respiratory disease including asthma and COPD

Any nondiabetic cause of neuropathy

All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).

Not able to read, write and/or understand Danish

Breastfeeding

Nephropathy requiring dialysis

Beta-blocker-use

Hyperkalemia at sceening visit (serum potassium >4.8 mmol/l)

eGFR < 25 ml/min/1.73m2

serum potassium > 4.8 mmol/l (at randomization)

have received chemotherapeutic treatment within last 12 months

Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit

Lactose intolerance

Grapefruit consumption that cannot be discontinued during the study period

Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit

Severe hepatic impairment

inability to complete study protocol, assessed to investigator

Definite CAN (more than one abnormal CART)

HbA1C >100 mmol/mol

Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient’s primary physician, who is not involved in this study, will determine if discontinuation is possible

Atrial fibrillation/flutter

Congestive heart failure (NYHA class 3-4)

History of cardiac arrhythmia

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The CART E/I ratio (by the Vagustm device)		The CART E/I ratio (by the Vagustm device)

Secondary Outcome Measures

Name	Time	Method
Cardiovascular reflex tests: R/S ratio, Valsalva manoeuvre (CARTs)		Cardiovascular reflex tests: R/S ratio, Valsalva manoeuvre (CARTs)
HRV indices (SDNN, RMSSD, Low and high-frequency power) (by the Vagustm device)		HRV indices (SDNN, RMSSD, Low and high-frequency power) (by the Vagustm device)
Fibrosis markers (serum PRO-C6 and C3M assessed by ELISA)		Fibrosis markers (serum PRO-C6 and C3M assessed by ELISA)
Fibrosis markers in skin biopsies (Pro-C6 and C3M by immunostaining (Only week 0, 36, 78)		Fibrosis markers in skin biopsies (Pro-C6 and C3M by immunostaining (Only week 0, 36, 78)

Trial Locations

Locations (2): Steno Diabetes Center Copenhagen
🇩🇰
Herlev, Denmark
Steno Diabetes Center North Denmark
🇩🇰
Aalborg, Denmark
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark
Peter Rossing
Site contact
+4530913383
peter.rossing@regionh.dk