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Stromal cell-derived factor-1 (SDF-1) is expressed in diverse organs including the kidneys and is cleaved and inactivated by DPP-4 enzyme. The aim of this study was to conduct a randomised controlled trial to assess the effect of sitagliptin on diabetic nephropathy when used as an add-on therapy to the advanced hybrid closed-loop (AHCL) system in adolescents with type 1 diabetes and nephropathy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This open-label, parallel-group, randomised controlled trial took place at the Pediatric Diabetes Clinic, Ain Shams University, Egypt. Forty-six adolescents aged 14.13 \u00b1 2.43 years on the MiniMed 780G system for at least 6 months before study, with HbA<jats:sub>1c<\/jats:sub> \u226469 mmol\/mol (8.5%) and diabetic nephropathy in the form of microalbuminuria, were randomly assigned to two groups (<jats:italic>n<\/jats:italic>=23 for each) based on a computer-generated randomisation sequence. The intervention group received oral sitagliptin 50 mg for 3 months. The other group used AHCL only and served as a control group. The primary outcome measure was the change in urinary albumin\/creatinine ratio (UACR) after 3 months of administration of sitagliptin. The key secondary outcome measure was the change from baseline in SDF-1 levels after treatment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Data for all participants were analysed. No significant difference was found between the groups as regards baseline clinical and laboratory characteristics as well as AHCL system settings (<jats:italic>p<\/jats:italic>&gt;0.05). Serum SDF-1 levels were higher in all individuals with type 1 diabetes vs healthy control individuals (<jats:italic>p<\/jats:italic>&lt;0.001). After 3 months, sitagliptin resulted in a significant decrease of SDF-1 levels from 3.58 \u00b1 0.73 to 1.99 \u00b1 0.76 ng\/ml (<jats:italic>p<\/jats:italic>&lt;0.001), together with improvement of UACR from 7.27 \u00b1 2.41 to 1.32 \u00b1 0.31 mg\/mmol (<jats:italic>p<\/jats:italic>&lt;0.001). In addition, sitagliptin reduced postprandial glucose, sensor glucose, coefficient of variation and total daily dose of insulin, while time in range 3.9\u201310.0 mmol\/l (70\u2013180 mg\/dl) and insulin-to-carbohydrate ratio were significantly increased. Sitagliptin was safe and well-tolerated without severe hypoglycaemia or diabetic ketoacidosis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions\/interpretation<\/jats:title>\n                <jats:p>Sitagliptin as an add-on therapy to AHCL had a reno-protective effect for individuals with type 1 diabetes and diabetic nephropathy, in addition to the improvement of time in range while reducing glycaemic variability and without compromising safety.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Funding<\/jats:title>\n                <jats:p>This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT06115460.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Graphical abstract<\/jats:title>\n                \n              <\/jats:sec>","DOI":"10.1007\/s00125-024-06265-7","type":"journal-article","created":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T03:39:52Z","timestamp":1726285192000},"page":"2637-2649","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["The DPP-4 inhibitor sitagliptin improves glycaemic control and early-stage diabetic nephropathy in adolescents with type 1 diabetes using the MiniMed 780G advanced hybrid closed-loop system: a randomised controlled trial"],"prefix":"10.1007","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8713-0657","authenticated-orcid":false,"given":"Nancy S.","family":"Elbarbary","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1162-0171","authenticated-orcid":false,"given":"Eman A.","family":"Ismail","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8822-5391","authenticated-orcid":false,"given":"Manal H.","family":"El-Hamamsy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0789-7838","authenticated-orcid":false,"given":"Marwa Z.","family":"Ibrahim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4917-6392","authenticated-orcid":false,"given":"Amal A.","family":"Elkholy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,9,14]]},"reference":[{"issue":"5","key":"6265_CR1","doi-asserted-by":"publisher","first-page":"1449","DOI":"10.1007\/s00467-022-05689-w","volume":"38","author":"G Rivetti","year":"2023","unstructured":"Rivetti G, Hursh BE, Miraglia Del Giudice E, Marzuillo P (2023) Acute and chronic kidney complications in children with type 1 diabetes mellitus. 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This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 relationships and activities"}},{"value":"All authors (NSE, EAI, MHE-H, MZI, AAE) contributed substantially to the study design, analysis or interpretation of data; critically reviewed, drafted or edited the manuscript; and approved the final work for submission. NSE is responsible for the integrity of the work as a whole.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Contribution statement"}}]}}