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The Differential Effects of Diabetes Therapy on Inflammation

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University College Dublin

Status

Completed

Conditions

Diabetic Nephropathy
Type 2 Diabetes

Treatments

Drug: Dipeptidyl-Peptidase IV Inhibitors
Drug: Glucagon-Like Peptide 1

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02150707
DPP4201401

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

30+ years old

Volunteers

No 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

Trial design

17 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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