The Differential Effects of Diabetes Therapy on Inflammation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02150707

Enrollment

Registered

2014-05-30

Start date

2014-05-31

Completion date

2015-12-31

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy, Type 2 Diabetes

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.

Interventions

DRUGDipeptidyl-Peptidase IV Inhibitors

Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia

DRUGGlucagon-Like Peptide 1

Glucagon-Like Peptide 1 to treat hyperglycaemia

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio	6 months

Secondary

Measure	Time frame
Albumin:creatinine ratio	6 months

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026