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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02150707
Other study ID # DPP4201401
Secondary ID
Status Completed
Phase N/A
First received May 27, 2014
Last updated May 17, 2016
Start date May 2014
Est. completion date December 2015

Study information

Verified date May 2016
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority Ireland: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Description:

In this prospective cohort study, patients who are clinically determined to require escalation of their glycaemic therapy, and prescribed a DPP4 inhibitor, GLP-1 receptor agonist, or insulin, will be invited to participate.

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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
Dipeptidyl-Peptidase IV Inhibitors
Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
Glucagon-Like Peptide 1
Glucagon-Like Peptide 1 to treat hyperglycaemia

Locations

Country Name City State
Ireland Mater Misericordiae University Hospital Dublin

Sponsors (5)

Lead Sponsor Collaborator
University College Dublin Eli Lilly and Company, Irish Endocrine Society, Merck Sharp & Dohme Corp., Royal College of Physicians

Country where clinical trial is conducted

Ireland, 

References & Publications (4)

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

Outcome

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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