The Differential Effects of Diabetes Therapy on Inflammation

NCT ID: NCT02150707

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Nephropathy Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dipeptidyl-Peptidase IV Inhibitors

Newly started on DPP4 inhibitor for hyperglycaemia

Dipeptidyl-Peptidase IV Inhibitors

Intervention Type DRUG

Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia

Glucagon-Like Peptide 1

Newly started on GLP-1 for hyperglycaemia or obesity

Glucagon-Like Peptide 1

Intervention Type DRUG

Glucagon-Like Peptide 1 to treat hyperglycaemia

Interventions

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Dipeptidyl-Peptidase IV Inhibitors

Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia

Intervention Type DRUG

Glucagon-Like Peptide 1

Glucagon-Like Peptide 1 to treat hyperglycaemia

Intervention Type DRUG

Other Intervention Names

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DPP4 inhibitors Liraglutide Exenatide

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Irish Endocrine Society

OTHER

Sponsor Role collaborator

Royal College of Physicians

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Karl Neff

Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donal O'Shea, MD FRCPI

Role: STUDY_DIRECTOR

University College Dublin

Carel W le Roux, PhD MB FRCP

Role: STUDY_DIRECTOR

University College Dublin

Mensud Hatunic, MD MRCPI

Role: STUDY_DIRECTOR

University College Dublin

Locations

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Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type BACKGROUND
PMID: 22608055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24362727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21206136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21284481 (View on PubMed)

Other Identifiers

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DPP4201401

Identifier Type: -

Identifier Source: org_study_id

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