The Effects of Dapagliflozin on HDL Particles Subtypes and Reverse Cholesterol Transport in Type 2 Diabetic Patients

Sponsor
University of Padova
Study ID
NCT02327039
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Sodium glucose cotransporter-2 inhibitor
  • Placebo — DRUG
    Tables of Dapagliflozin placebo

Study Details

In Phase 2b/3 clinical trials, Dapagliflozin has been shown to raise HDL cholesterol levels by about 4 mg/dl (1 mmol/l), which is generally considered a clinically-meaningful change. As this HDL cholesterol increase is carried out with concomitant improvement in glucotoxicity and body weight reduction, it is possible that treatment with Dapagliflozin also improves HDL function. This is important because clinical, epidemiological and experimental studies indicate that HDL function may be more important than HDL cholesterol levels in determining the protective cardiovascular effects of HDL particles. In addition, knowing the effects of Dapagliflozin on HDL function can help interpreting the increase in HDL cholesterol levels observed in Dapagliflozin-treated patients. Finally, discovery of extra-glycemic effects of Dapagliflozin will shed new light on the potential benefits of therapy with Dapagliflozin and SGLT2i in general. So far, no study evaluated the effects of Dapagliflozin (or other SGLT2i) on HDL function. The investigators hypothesize that Dapagliflozin, in addition to raising HDL cholesterol levels, also increases HDL functionality, measured as reverse cholesterol transport and anti-oxidant capacity, in patients with T2DM

Key Dates

Start date
Mar 31, 2015
Status verified
Jul 2019
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg tablet once daily for 12 weeks
  • Placebo Comparator: Placebo
    Placebo 10 mg tablet once daily for 12 weeks

Primary Outcome Measure

Change from baseline in reverse cholesterol transport, measured as cholesterol efflux capacity of patient's plasma [ Time Frame: 12 weeks ]

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