The Differential Effects of Diabetes Therapy on Inflammation

Type 2 Diabetes Clinical Trial

Official title:

The Differential Effects of Diabetes Therapy on Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150707
• Other study ID #: DPP4201401
• 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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Type 2 Diabetes

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