The Differential Effects of Diabetes Therapy on Inflammation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Differential Effects of Diabetes Therapy on Inflammation

Conditions
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Diabetic Nephropathy, Type 2 Diabetes

Intervention / Treatment
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* Drug: Dipeptidyl-Peptidase IV Inhibitors
* Drug: Glucagon-Like Peptide 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dipeptidyl-Peptidase IV Inhibitors<br>Newly started on DPP4 inhibitor for hyperglycaemia | Drug: Dipeptidyl-Peptidase IV Inhibitors<br>* Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia<br>* Other names: DPP4 inhibitors;|
| Glucagon-Like Peptide 1<br>Newly started on GLP-1 for hyperglycaemia or obesity | Drug: Glucagon-Like Peptide 1<br>* Glucagon-Like Peptide 1 to treat hyperglycaemia<br>* Other names: Exenatide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin:creatinine ratio |  | 6 months |