Evidence map›Paper›PMID 28376855›Full record

Trial reportCardiovascular diabetology2017

Effects of the SGLT2 inhibitor dapagliflozin on HDL cholesterol, particle size, and cholesterol efflux capacity in patients with type 2 diabetes: a randomized placebo-controlled trial.

Gian Paolo Fadini, Benedetta Maria Bonora, Giancarlo Zatti, Nicola Vitturi, Elisabetta Iori, Maria Cristina Marescotti, Mattia Albiero, Angelo Avogaro

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular diabetology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02327039. Cited by 62 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 7 pooled it
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02327039 phase4completed

The Effects of Dapagliflozin on HDL Particles Subtypes and Reverse Cholesterol Transport in Type 2 Diabetic Patients. A 12 Weeks Randomized Placebo-controlled Phase IV Study

Ran2015Enrolled33Registered outcomes9Posted comparisons0ConditionsType 2 DiabetesArmsdapagliflozin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 7 syntheses or guidelines pooled it, 111 citations in OpenAlex.

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2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Gian Paolo FadiniDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy. gianpaolofadini@hotmail.com.ORCID 0000-0002-6510-2097
Benedetta Maria BonoraDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Giancarlo ZattiDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Nicola VitturiDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Elisabetta IoriDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Maria Cristina MarescottiDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Mattia AlbieroDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Angelo AvogaroDepartment of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
University of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium-glucose co-transporter-2 inhibitors (SGLT2i) reduce glucose levels, body weight, and blood pressure, possibly resulting in cardiovascular protection. In phase III trials, SGLT2i were shown to increase HDL cholesterol. We aimed to evaluate whether the SGLT2i dapagliflozin affects HDL function in a randomized placebo-controlled trial.

methodsThirty-three type 2 diabetic patients were randomized to receive dapagliflozin 10 mg or placebo for 12 weeks on top of their glucose lowering medications. The primary end-point was the change in cholesterol efflux capacity (CEC) from macrophages at study end versus baseline. Secondary endpoints were changes in: distribution of HDL subfractions, lipid profile, activity of enzymes that mediate HDL antioxidant properties (PON1 and ARE) and cholesterol metabolism (CETP), HbA1c, body weight and composition.

resultsThirty-one patients completed the study, n = 16 in the placebo group and n = 15 in the dapagliflozin group. Patients randomized to dapagliflozin were older and had lower adiposity indexes, although these differences disappeared after correction for multiple testing. Therapy with dapagliflozin reduced HbA1c by 0.9% and body weight by 3.1 kg, mainly attributable to reduction of body water and lean mass. As compared to placebo, dapagliflozin reduced CEC (-6.7 ± 2.4 versus 0.3 ± 1.8%; p = 0.043), but this effect was no longer significant after adjusting for age and BMI. No change was detected in HDL cholesterol, HDL subfractions, activity of PON1, ARE, and CETP.

conclusionsDespite improvements in glucose control and reduction in body weight, therapy with dapagliflozin exerted no significant effect on HDL cholesterol levels and HDL functionality. Trial registration EudraCT 2014-004270-42; NCT02327039.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAgedBenzhydryl CompoundsBlood GlucoseBody WeightCholesterol, HDLDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleFollow-Up StudiesGlucosidesHumansMaleMiddle AgedParticle SizeSodium-Glucose Transporter 2Benzhydryl CompoundsBlood GlucoseCholesterol, HDLdapagliflozinGlucosidesSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsAtherosclerosisBody compositionTherapy

Identifiers

PMID28376855
PMCPMC5379610
OpenAlexW2604205657

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.