The Differential Effects of Diabetes Therapy on Inflammation

NCT02150707 | Completed

• 1 other identifier: DPP4201401
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• Albumin:creatinine ratio

  6 months

Study Arms (2)

Dipeptidyl-Peptidase IV Inhibitors

Newly started on DPP4 inhibitor for hyperglycaemia

Drug: Dipeptidyl-Peptidase IV Inhibitors

Glucagon-Like Peptide 1

Newly started on GLP-1 for hyperglycaemia or obesity

Drug: Glucagon-Like Peptide 1

Interventions

Dipeptidyl-Peptidase IV Inhibitors DRUG

Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia

Also known as: DPP4 inhibitors

Dipeptidyl-Peptidase IV Inhibitors

Glucagon-Like Peptide 1 DRUG

Glucagon-Like Peptide 1 to treat hyperglycaemia

Also known as: Liraglutide, Exenatide

Glucagon-Like Peptide 1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Irish Endocrine Society: collaborator
• Royal College of Physicians: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Dublin 7, Ireland

Location

Related Publications (4)

• 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.

  PMID: 22608055 BACKGROUND

• 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.

  PMID: 24362727 BACKGROUND

• 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.

  PMID: 21206136 BACKGROUND

• 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.

  PMID: 21284481 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2

Interventions

Dipeptidyl-Peptidase IV Inhibitors; Glucagon-Like Peptide 1; Liraglutide; Exenatide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

IE (1)