- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150707
The Differential Effects of Diabetes Therapy on Inflammation
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dublin, Ireland, Dublin 7
- Mater Misericordiae University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
|
Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
Other Names:
|
Glucagon-Like Peptide 1
Newly started on GLP-1 for hyperglycaemia or obesity
|
Glucagon-Like Peptide 1 to treat hyperglycaemia
Other Names:
|
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
Sponsor
Collaborators
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
General Publications
- Fenske WK, Dubb S, Bueter M, Seyfried F, Patel K, Tam FW, Frankel AH, le Roux CW. Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study. Surg Obes Relat Dis. 2013 Jul-Aug;9(4):559-68. doi: 10.1016/j.soard.2012.03.009. Epub 2012 Apr 10.
- Hogan AE, Gaoatswe G, Lynch L, Corrigan MA, Woods C, O'Connell J, O'Shea D. Glucagon-like peptide 1 analogue therapy directly modulates innate immune-mediated inflammation in individuals with type 2 diabetes mellitus. Diabetologia. 2014 Apr;57(4):781-4. doi: 10.1007/s00125-013-3145-0. Epub 2013 Dec 21.
- Hattori S. Sitagliptin reduces albuminuria in patients with type 2 diabetes. Endocr J. 2011;58(1):69-73. doi: 10.1507/endocrj.k10e-382. Epub 2010 Dec 28.
- Wu JD, Xu XH, Zhu J, Ding B, Du TX, Gao G, Mao XM, Ye L, Lee KO, Ma JH. Effect of exenatide on inflammatory and oxidative stress markers in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011 Feb;13(2):143-8. doi: 10.1089/dia.2010.0048.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Inflammation
- Diabetic Nephropathies
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Anti-Obesity Agents
- Incretins
- Liraglutide
- Glucagon
- Exenatide
- Dipeptidyl-Peptidase IV Inhibitors
- Glucagon-Like Peptide 1
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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