type 2 diabetes
Conditions
Brief summary
Endpoint related to Objective #1: to verify the effect of SGLT-2is on HRV as shown by the difference in LF:HF ratio (a frequency domain measured as improvement of 20% in LF:HF ratio from baseline to end of treatment (6 months)., Endpoint related to Objective #2: to verify the effect of SGLT-2 on CAN progression as shown by the improvement in at least one of the three CART parameter AND an improvement in glucose variability from baseline to end of treatment (6 months)
Detailed description
to assess the results of SGLT2i treatment on pancreatic beta cell function (i.e., glucose sensitivity and insulin secretion parameters including those derived from the Mixed Meal Test (MMT)) in patients with and without CAN after 6 months intervention with SGLT2i., to assess the difference in glycemic variability expressed as mean amplitude of glycemic excursions (MAGE) measured for 2 weeks flash glucose monitoring at baseline and after 6 months of treatment with SGLT-2i., to explore difference in CAN progression expressed as changes in cardiovascular autonomic reflex tests (CARTs) as defined by: a) expiration/inspiration (E/I) ratio, b) 30:15 ratio and c) Valsalva ratio.
Interventions
DRUGSEMAGLUTIDE
DRUGEMPAGLIFLOZIN
DRUGSITAGLIPTIN
DRUGINSULIN DEGLUDEC
DRUGPIOGLITAZONE
DRUGCANAGLIFLOZIN
DRUGERTUGLIFLOZIN
DRUGDAPAGLIFLOZIN
DRUGINSULIN ASPART
DRUGINSULIN LISPRO
DRUGLINAGLIPTIN
DRUGINSULIN GLARGINE
Sponsors
Universita Cattolica Del Sacro Cuore
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint related to Objective #1: to verify the effect of SGLT-2is on HRV as shown by the difference in LF:HF ratio (a frequency domain measured as improvement of 20% in LF:HF ratio from baseline to end of treatment (6 months)., Endpoint related to Objective #2: to verify the effect of SGLT-2 on CAN progression as shown by the improvement in at least one of the three CART parameter AND an improvement in glucose variability from baseline to end of treatment (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| to assess the results of SGLT2i treatment on pancreatic beta cell function (i.e., glucose sensitivity and insulin secretion parameters including those derived from the Mixed Meal Test (MMT)) in patients with and without CAN after 6 months intervention with SGLT2i., to assess the difference in glycemic variability expressed as mean amplitude of glycemic excursions (MAGE) measured for 2 weeks flash glucose monitoring at baseline and after 6 months of treatment with SGLT-2i., to explore difference in CAN progression expressed as changes in cardiovascular autonomic reflex tests (CARTs) as defined by: a) expiration/inspiration (E/I) ratio, b) 30:15 ratio and c) Valsalva ratio. | — |
Countries
Italy
Outcome results
None listed