BACKGROUND: Moderate to severe @entity1569 is a systemic @entity32 associated with insulin resistance, @entity28 and @entity164 2 @entity6 (T2DM). @entity12350 is a @entity5735 ( @entity5735 ) inhibitor that improves glycaemia and has a marketing authorisation for the treatment of T2DM. Non-immunosuppressive therapies that are effective for @entity1569 and its associated comorbidities would be a significant advance in the treatment of this @entity102 . METHODS/DESIGN: This is a single centre, 39-week, prospective, randomised, open label, clinical trial of oral @entity12350 (Januvia(  )) in @entity1569 @entity1 who are due to undergo a course of narrow-band ultraviolet-B (NB-UVB) phototherapy. We plan to enrol 120 @entity1 and allocate @entity1 on a random and 1:1 basis to receive @entity12350 100  mg daily for 24  weeks combined with NB-UVB or NB-UVB monotherapy. @entity1 will be followed up for 12  weeks after @entity12350 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 @entity1569 , proportions of @entity1 who achieve PASI-50 (50  % reduction in PASI from baseline), PASI-75, PASI-90 and the proportion of @entity1 who relapse in each group. We will also analyse changes in @entity65 risk factors, serum cytokine and hormone levels and peripheral blood mononuclear expression of immune proteins at 24 and 36  weeks. A subgroup of @entity1 will have skin biopsies taken and analysed for skin levels and expression of immune cells, receptors, hormones and immune proteins. The genetic or epigenetic profile that predicts best response to @entity5735 inhibitor therapy will be analysed. The safety endpoints include the rate and severity of adverse events. DISCUSSION: This is the first randomised clinical trial assessing @entity5735 inhibition therapy in @entity1569 . We hypothesise that @entity12350 therapy in combination with NB-UVB improves @entity1569 severity compared to NB-UVB monotherapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02347501 (Date of registration: 27 January 2015).

@entity5735 inhibition and narrow-band ultraviolet-B light in XXXX (DINUP): study protocol for a randomised controlled trial.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients', 'Participants'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammatory disease'] @entity1569 :: ('MESH:D011565', 'Disease') :: ['psoriasis'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity28 :: ('MESH:D009765', 'Disease') :: ['obesity'] @entity5735 :: ('1803', 'Gene') :: ['dipeptidyl peptidase-4', 'DPP-4'] @entity102 :: ('MESH:D002908', 'Disease') :: ['chronic disease'] @entity12350 :: ('MESH:C496398', 'Chemical') :: ['Sitagliptin', 'sitagliptin'] @entity164 :: ('MESH:D017827', 'Disease') :: ['type'] @entity65 :: ('MESH:D002318', 'Disease') :: ['cardiovascular disease']
@entity1569 :: (MESH:D011565,Disease) :: ['psoriasis']
