Skip to main content
OpenTrials
Completed

NCT Number: NCT02150707

The Differential Effects of Diabetes Therapy on Inflammation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mater Misericordiae University Hospital

Dublin, Dublin 7, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dipeptidyl-Peptidase IV Inhibitors

Drug

Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia

Other names: DPP4 inhibitors

Glucagon-Like Peptide 1

Drug

Glucagon-Like Peptide 1 to treat hyperglycaemia

Other names: Liraglutide, Exenatide

Primary outcomes

  1. Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio

    Time frame: 6 months

Secondary outcomes

  1. Albumin:creatinine ratio

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • Eli Lilly and Company
  • Irish Endocrine Society
  • Merck Sharp & Dohme LLC
  • Royal College of Physicians

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 30, 2014
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.