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The Differential Effects of Diabetes Therapy on Inflammation

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ClinicalTrials.gov Identifier: NCT02150707
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
Irish Endocrine Society
Royal College of Physicians
Merck Sharp & Dohme Corp.
Eli Lilly and Company
Information provided by (Responsible Party):
Karl Neff, University College Dublin

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.

Condition or disease Intervention/treatment
Diabetic Nephropathy Type 2 Diabetes Drug: Dipeptidyl-Peptidase IV Inhibitors Drug: Glucagon-Like Peptide 1

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.


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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Differential Effects of Diabetes Therapy on Inflammation
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

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 Name: 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




Primary Outcome Measures :
  1. Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Albumin:creatinine ratio [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150707


Locations
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Ireland
Mater Misericordiae University Hospital
Dublin, Ireland, Dublin 7
Sponsors and Collaborators
University College Dublin
Irish Endocrine Society
Royal College of Physicians
Merck Sharp & Dohme Corp.
Eli Lilly and Company
Investigators
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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:
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Responsible Party: Karl Neff, Clinical Research Fellow, University College Dublin
ClinicalTrials.gov Identifier: NCT02150707     History of Changes
Other Study ID Numbers: DPP4201401
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Diabetic Nephropathies
Diabetes Mellitus
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Diabetes Complications
Dipeptidyl-Peptidase IV Inhibitors
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action