Dipeptidyl peptidase-4 inhibition and narrow-band ultraviolet-B light in psoriasis (DINUP): study protocol for a randomised controlled trial

Trials
Maeve LynchBrian Kirby

Abstract

Moderate to severe psoriasis is a systemic inflammatory disease associated with insulin resistance, obesity and type 2 diabetes (T2DM). Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that improves glycaemia and has a marketing authorisation for the treatment of T2DM. Non-immunosuppressive therapies that are effective for psoriasis and its associated comorbidities would be a significant advance in the treatment of this chronic disease. This is a single centre, 39-week, prospective, randomised, open label, clinical trial of oral sitagliptin (Januvia(®)) in psoriasis patients who are due to undergo a course of narrow-band ultraviolet-B (NB-UVB) phototherapy. We plan to enrol 120 participants and allocate participants on a random and 1:1 basis to receive sitagliptin 100 mg daily for 24 weeks combined with NB-UVB or NB-UVB monotherapy. Participants will be followed up for 12 weeks after sitagliptin therapy is discontinued. The primary endpoint is the change in Psoriasis Area and Severity Index (PASI) 24 weeks after treatment initiation. Secondary endpoints include cumulative NB-UVB dose, number of NB-UVB treatments required to clear psoriasis, proportions of participants who achieve PASI-50 (50 % reduction in PASI from ba...Continue Reading

References

Jun 1, 1996·The British Journal of Dermatology·M NovelliM G Bernengo
Aug 15, 2003·The New England Journal of Medicine·Vera M R HeydendaelMenno A de Rie
Mar 11, 2004·Journal of the European Academy of Dermatology and Venereology : JEADV·G ChodorowskaM Juszkiewicz-Borowiec
Jun 17, 2006·The Journal of Investigative Dermatology·Anja ThielitzHarald Gollnick
Oct 21, 2006·Journal of the American Academy of Dermatology·Andrea L NeimannJoel M Gelfand
Jun 15, 2007·Current Medical Research and Opinion·Markolf HanefeldUNKNOWN Sitagliptin Study 014 Investigators
Jul 31, 2007·Lancet·Christopher Em Griffiths, Jonathan Nwn Barker
Oct 16, 2007·Diabetes Research and Clinical Practice·Kenji NonakaPeter P Stein
Dec 19, 2007·Archives of Dermatology·Joel M GelfandBrian L Strom
Apr 4, 2008·The British Journal of Dermatology·R G van LingenP E J van Erp
Dec 18, 2009·Metabolism: Clinical and Experimental·Giuseppe DerosaArrigo F G Cicero
Jan 15, 2010·Diabetes, Obesity & Metabolism·P AschnerUNKNOWN Sitagliptin Study 049 Group
Jan 15, 2010·The New England Journal of Medicine·Christopher E M GriffithsUNKNOWN ACCEPT Study Group
Mar 9, 2010·American Journal of Physiology. Heart and Circulatory Physiology·Yumei YeYochai Birnbaum
Jul 27, 2010·Journal of the American Academy of Dermatology·Eric W HosslerChris M Mowad
Nov 20, 2010·Cardiovascular Drugs and Therapy·Barbara HuisamenAmanda Lochner
Jan 6, 2011·Endocrine Journal·Sachiko Hattori
Jan 14, 2011·Diabetes, Obesity & Metabolism·A J TremblayP Couture
Jan 20, 2011·International Journal of Immunopathology and Pharmacology·P GisondiG Girolomoni
Mar 17, 2011·Advances in Clinical Chemistry·Kei OhnumaChikao Morimoto
Jun 1, 2011·International Journal of Dermatology·Nuzhatun Nisa, Qazi Ahmed
Nov 8, 2011·Dermatology : International Journal for Clinical and Investigative Dermatology·Tatsuya NishiokaKozo Hashimoto
Jan 5, 2012·Advances in Therapy·Matteo MonamiEdoardo Mannucci
Jun 14, 2012·Journal of the European Academy of Dermatology and Venereology : JEADV·T AhernD O'Shea
Jun 30, 2012·The Journal of Clinical Endocrinology and Metabolism·Antoine MakdissiParesh Dandona
Sep 28, 2012·The Journal of Investigative Dermatology·Rosa ParisiUNKNOWN Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team
Oct 16, 2012·Metabolism: Clinical and Experimental·Noriko Satoh-AsaharaAkira Shimatsu
Dec 25, 2012·The Journal of Clinical Endocrinology and Metabolism·Scott R GoodwinKevin E Yarasheski

❮ Previous
Next ❯

Citations

Sep 1, 2017·Journal of Biopharmaceutical Statistics·Richard F Potthoff
Jan 25, 2018·Diabetes, Obesity & Metabolism·Carolyn F Deacon
Dec 2, 2020·International Journal of Molecular Sciences·Ji-Eun Chang, Min Sik Choi
Sep 12, 2020·European Journal of Clinical Investigation·Ching-Chi ChiTao-Hsin Tung
Jun 15, 2021·International Immunopharmacology·Shabnam RadbakhshAmirhossein Sahebkar

❮ Previous
Next ❯

Methods Mentioned

BETA
pregnancy test
contraception
gastric bypass

Clinical Trials Mentioned

NCT02347501

Software Mentioned

SPSS

Related Concepts

Related Feeds

Antipsychotic-Induced Weight Gain

Antipsychotic-induced weight gain (aiwg) is a common adverse effect of this treatment, particularly with second-generation antipsychotics, and it is a major health problem around the world. Here are the latest discoveries pertaining to AIWG.

Cardiovascular Disease Pathophysiology

Cardiovascular disease involves several different processes that contribute to the pathological mechanism, including hyperglycemia, inflammation, atherosclerosis, hypertension and more. Vasculature stability plays a critical role in the development of the disease. Discover the latest research on cardiovascular disease pathophysiology here.

CV Disorders & Type 2 Diabetes

This feed focuses on the association of cardiovascular diseases in patients with type 2 diabetes.