The Differential Effects of Diabetes Therapy on Inflammation
NCT ID: NCT02150707
Last Updated: 2016-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
17 participants
OBSERVATIONAL
2014-05-31
2015-12-31
Brief Summary
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Detailed Description
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Blood and urine samples will be taken before, 4 to 8 weeks after, and 26 weeks after starting the new therapy. Markers of inflammation, renal function and glycemic control will be measured at each timepoint.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dipeptidyl-Peptidase IV Inhibitors
Newly started on DPP4 inhibitor for hyperglycaemia
Dipeptidyl-Peptidase IV Inhibitors
Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
Glucagon-Like Peptide 1
Newly started on GLP-1 for hyperglycaemia or obesity
Glucagon-Like Peptide 1
Glucagon-Like Peptide 1 to treat hyperglycaemia
Interventions
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Dipeptidyl-Peptidase IV Inhibitors
Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
Glucagon-Like Peptide 1
Glucagon-Like Peptide 1 to treat hyperglycaemia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 2 diabetes for one year or more
* Diagnosis of DKD as defined by two distinct albumin:creatinine ratio measurements above the gender specific range in the local reference laboratory with an interval of no less than eight week between measurements
* Stable dose of an inhibitor of the renin angiotensin system for a period of 8 weeks
Exclusion Criteria
* Substance abuse including alcohol excess
* Use of a GLP-1 analogue in the last 6 months
* Pregnancy
* Hypersensitivity to the prescribed treatment
30 Years
ALL
No
Sponsors
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Irish Endocrine Society
OTHER
Royal College of Physicians
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Eli Lilly and Company
INDUSTRY
University College Dublin
OTHER
Responsible Party
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Karl Neff
Clinical Research Fellow
Principal Investigators
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Donal O'Shea, MD FRCPI
Role: STUDY_DIRECTOR
University College Dublin
Carel W le Roux, PhD MB FRCP
Role: STUDY_DIRECTOR
University College Dublin
Mensud Hatunic, MD MRCPI
Role: STUDY_DIRECTOR
University College Dublin
Locations
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Mater Misericordiae University Hospital
Dublin, , Ireland
Countries
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References
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Fenske WK, Dubb S, Bueter M, Seyfried F, Patel K, Tam FW, Frankel AH, le Roux CW. Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study. Surg Obes Relat Dis. 2013 Jul-Aug;9(4):559-68. doi: 10.1016/j.soard.2012.03.009. Epub 2012 Apr 10.
Hogan AE, Gaoatswe G, Lynch L, Corrigan MA, Woods C, O'Connell J, O'Shea D. Glucagon-like peptide 1 analogue therapy directly modulates innate immune-mediated inflammation in individuals with type 2 diabetes mellitus. Diabetologia. 2014 Apr;57(4):781-4. doi: 10.1007/s00125-013-3145-0. Epub 2013 Dec 21.
Hattori S. Sitagliptin reduces albuminuria in patients with type 2 diabetes. Endocr J. 2011;58(1):69-73. doi: 10.1507/endocrj.k10e-382. Epub 2010 Dec 28.
Wu JD, Xu XH, Zhu J, Ding B, Du TX, Gao G, Mao XM, Ye L, Lee KO, Ma JH. Effect of exenatide on inflammatory and oxidative stress markers in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011 Feb;13(2):143-8. doi: 10.1089/dia.2010.0048.
Other Identifiers
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DPP4201401
Identifier Type: -
Identifier Source: org_study_id
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