The Differential Effects of Diabetes Therapy on Inflammation

May 17, 2016 updated by: Karl Neff, University College Dublin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 7
        • Mater Misericordiae University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will be a prospective cohort study with 120 participants: 40 per group. I have calculated this sample size to achieve a 90% power based on a 50% reduction in urinary chemokines and circulating pro-inflammatory immune cells 1-4. This power calculation anticipates a 10% dropout rate.

Patients with DKD presenting to the diabetes service of St Vincent's University Hospital (SVUH) and Mater Misericordiae University Hospital (MMUH) who are commenced on GLP-1, DPP4i or insulin for the first time will be invited to participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dipeptidyl-Peptidase IV Inhibitors
Newly started on DPP4 inhibitor for hyperglycaemia
Drug: Dipeptidyl-Peptidase IV Inhibitors
Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
Other Names:
  • DPP4 inhibitors
Glucagon-Like Peptide 1
Newly started on GLP-1 for hyperglycaemia or obesity
Drug: Glucagon-Like Peptide 1
Glucagon-Like Peptide 1 to treat hyperglycaemia
Other Names:
  • Liraglutide
  • Exenatide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Albumin:creatinine ratio
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

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

Investigators

  • Study Director: Donal O'Shea, MD FRCPI, University College Dublin
  • Study Director: Carel W le Roux, PhD MB FRCP, University College Dublin
  • Study Director: Mensud Hatunic, MD MRCPI, University College Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (ESTIMATE)

May 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPP4201401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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