Diabetic NephropathyNCT02150707
The Differential Effects of Diabetes Therapy on Inflammation
An observational study of Diabetic Nephropathy and Type 2 Diabetes, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Nephropathy, Type 2 Diabetes
- What is being tested?
- Dipeptidyl-Peptidase IV Inhibitors and Glucagon-Like Peptide 1
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- 1 siteIreland
- Study dates
- May 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes
- Being tested
- Dipeptidyl-Peptidase IV Inhibitors, Glucagon-Like Peptide 1
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipeptidyl-Peptidase IV InhibitorsDrug
Also called DPP4 inhibitors
Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
Glucagon-Like Peptide 1Drug
Also called Liraglutide, Exenatide
Glucagon-Like Peptide 1 to treat hyperglycaemia
| Study group | Role | What they receive |
|---|---|---|
| Dipeptidyl-Peptidase IV Inhibitors | Newly started on DPP4 inhibitor for hyperglycaemia Receives: Drug: Dipeptidyl-Peptidase IV Inhibitors | |
| Glucagon-Like Peptide 1 | Newly started on GLP-1 for hyperglycaemia or obesity Receives: Drug: Glucagon-Like Peptide 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio
Measured: 6 months
Secondary outcomes (1)
Albumin:creatinine ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Endocrine Society, Royal College of Physicians, Merck Sharp & Dohme LLC, Eli Lilly and Company
- Responsible party
- Principal investigator, Karl Neff, University College Dublin
- Investigators
- Donal O'Shea, MD FRCPI, Study director, University College DublinCarel W le Roux, PhD MB FRCP, Study director, University College DublinMensud Hatunic, MD MRCPI, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150707
- Sponsor's protocol ID
- DPP4201401
- Status last verified
- May 2016
- First submitted
- 27 May 2014
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22608055Hogan 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.
PubMed 24362727Hattori 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.
PubMed 21206136Wu 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.
PubMed 21284481
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Effects of Diabetes Therapy on Inflammation
- ClinicalTrials.gov ID
- NCT02150707
- Acronym / sponsor ID
- DPP4201401
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Irish Endocrine Society, Royal College of Physicians, Merck Sharp & Dohme LLC, Eli Lilly and Company
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipeptidyl-Peptidase IV Inhibitors | – | Drug: Dipeptidyl-Peptidase IV InhibitorsNewly started on DPP4 inhibitor for hyperglycaemia |
| Glucagon-Like Peptide 1 | – | Drug: Glucagon-Like Peptide 1Newly started on GLP-1 for hyperglycaemia or obesity |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipeptidyl-Peptidase IV InhibitorsAlso: DPP4 inhibitorsDipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia | Drug | Dipeptidyl-Peptidase IV Inhibitors |
| Glucagon-Like Peptide 1Also: Liraglutide, ExenatideGlucagon-Like Peptide 1 to treat hyperglycaemia | Drug | Glucagon-Like Peptide 1 |
Primary outcome
Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio
Time frame: 6 months
1 secondary outcome
Albumin:creatinine ratio
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Background: PubMed 22608055Fenske 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.
- Background: PubMed 24362727Hogan 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.
- Background: PubMed 21206136Hattori 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.
- Background: PubMed 21284481Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donal O'Shea, MD FRCPI study director
University College Dublin
Carel W le Roux, PhD MB FRCP study director
University College Dublin
Mensud Hatunic, MD MRCPI study director
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy and Type 2 Diabetes, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte:chemoattractant protein 1 (MCP-1):creatinine ratio (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150707, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.