Type 2 Diabetes Clinical Trial
Official title:
The Differential Effects of Diabetes Therapy on Inflammation
Verified date | May 2016 |
Source | University College Dublin |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Research Ethics Committee |
Study type | Observational |
This study aims to determine if different diabetes treatments have different effects on inflammation; in particular, kidney inflammation. This type of inflammation is common in people with diabetes, and can lead to kidney failure. This study will investigate the effect of different types of diabetes treatment on kidney inflammation. This will help us to decide if certain types of medicine should be preferred in people with evidence of inflammation in their kidneys, as this may help prevent major complications including kidney failure.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - Age over 30 years - 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: - Any cognitive impediment that preclude the participant from giving free and informed consent - Substance abuse including alcohol excess - Use of a GLP-1 analogue in the last 6 months - Pregnancy - Hypersensitivity to the prescribed treatment |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ireland | Mater Misericordiae University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin | Eli Lilly and Company, Irish Endocrine Society, Merck Sharp & Dohme Corp., Royal College of Physicians |
Ireland,
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. — View Citation
Hattori S. Sitagliptin reduces albuminuria in patients with type 2 diabetes. Endocr J. 2011;58(1):69-73. Epub 2010 Dec 28. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio | 6 months | No | |
Secondary | Albumin:creatinine ratio | 6 months | No |
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