The Differential Effects of Diabetes Therapy on Inflammation

Completed

• Conditions: Type 2 Diabetes; Diabetic Nephropathy
• Interventions: Drug: Dipeptidyl-Peptidase IV Inhibitors; Drug: Glucagon-Like Peptide 1

• Registration Number: NCT02150707
• Lead Sponsor: University College Dublin

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dipeptidyl-Peptidase IV Inhibitors	Dipeptidyl-Peptidase IV Inhibitors	Newly started on DPP4 inhibitor for hyperglycaemia
Glucagon-Like Peptide 1	Glucagon-Like Peptide 1	Newly started on GLP-1 for hyperglycaemia or obesity

Primary Outcome Measures

Name	Time	Method
Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio	6 months

Secondary Outcome Measures

Name	Time	Method
Albumin:creatinine ratio	6 months

Trial Locations

Locations (1)

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland