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Systematic review and meta-analysis of the effect of SGLT-2 inhibitors on microvascular outcomes in patients with type 2 diabetes: a review protocol
  1. Edgar Gerardo Dorsey-Treviño1,2,
  2. Belinda Maricela Contreras-Garza1,2,
  3. José Gerardo González-González1,2,3,
  4. Neri Álvarez-Villalobos2,4,
  5. Alejandro Salcido-Montenegro1,2,
  6. Alejandro Díaz González-Colmenero1,2,
  7. Ann M Farrell5,
  8. Victoria González-Nava1,2,
  9. Giselle Rodríguez-Tamez1,2,
  10. Victor M Montori4,6,
  11. René Rodriguez-Gutierrez1,2,4,6
  1. 1 Endocrinology Division, Department of Internal Medicine, Hospital University "Dr. José E. González" Universidad Autónoma de Nuevo León, Monterrey, Mexico
  2. 2 Plataforma INVEST Medicina UANL – KER Unit Mayo Clinic (KER Unit México), Universidad Autónoma de Nuevo León, Monterrey, México
  3. 3 ResearchUnit, University Hospital “Dr. José E. González”, Universidad Autónoma de Nuevo León, Monterrey, México
  4. 4 Knowledge andEvaluation Research Unit in Endocrinology, Mayo Clinic, Rochester, MN, USA
  5. 5 Mayo Medical Library, Mayo Clinic, Rochester, MN, USA
  6. 6 Division of Endocrinology,Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, MN, USA
  1. Correspondence to Dr René Rodriguez-Gutierrez; rodriguezgutierrez.rene{at}mayo.edu

Abstract

Introduction Sodium glucose cotransporter 2 (SGLT-2) inhibitors are a relatively new drug-class of glucose-lowering medications. Several trials and systematic reviews have demonstrated their beneficial effect on some macrovascular outcomes. Their effect on microvascular outcomes has been reported as positive in several trials, however, their effect remains uncertain. Therefore, we report the protocol of a systematic review and meta-analysis aimed at determining the effect of SGLT-2 inhibitors regarding patient-important and surrogate microvascular outcomes in patients with type 2 diabetes.

Methods and analysis A comprehensive search will be conducted to find eligible articles from each database’s earliest inception to November 2017. These databases will include Ovid, MEDLINE, EMBASE, Web of Science, and Scopus. We will search for randomized controlled trials (RCTs) that compare any of the SGLT-2 inhibitors with any other active treatment or placebo assessing microvascular outcomes in either their primary or secondary outcomes. Reviewers working independently and in duplicate will review all abstracts, and full-text manuscripts for eligibility, and will systematically extract the data and will assess the risk of bias in the included studies. Random-effects models will also be used.

Ethics and dissemination The results of the systematic review will be disseminated via publication in a peer-reviewed journal regardless of outcome and will be presented at relevant conferences. The data we will use do not include individual patient data, so ethical approval is not required

PROSPERO registration number CRD42017076460.

  • sglt-2
  • diabetic retinopathy
  • diabetic neuropathy
  • peripheral vascularization

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • EGD-T and BMC-G contributed equally.

  • Contributors RR-G, EGD-T and BMC-G designed and wrote the protocol. EGD-T, AS-M, VG-N, GR-T, ADG-C, JGG-G, VMM and RR-G made substantial contribution and revision to it. NA-V and AS-M working with AMF will design the search strategy for this review. EGD-T, BMC-G, AS-M, VG-N, GR-T and ADG-C will undertake data collection. EGD-T and BMC-G will perform the statistical analysis of data. RR-G, EGD-T and BMC-G will interpret the results and write the final manuscript. JGG-G and VMM will work as second reviewer and third reviewer, respectively. The definitive version of this protocol reflects the contribution of all authors. All authors read and approved the final manuscript.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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