Diabetes Mellitus Clinical Trial
Official title:
Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation
Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x−rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Heart disease is the commonest cause of death in patients with diabetes. People with diabetes are more likely to need these tests/treatments. By identifying those at greater risk of kidney complications we may be able to make these tests/treatments safer and offer them to more patients with diabetes.
Diabetes mellitus is an important risk factor for the development of contrast induced
nephropathy (CIN), acting as a 'risk multiplier', amplifying the risk of acute kidney injury
in these patients. There are important prognostic implications following the development of
CIN and it is associated with a significantly increased mortality at 1 year. Diabetes is a
major risk factor for coronary disease and these patients often have significant
co−morbidities.
Currently creatinine is used to assess risk but this often lags behind clinical status.
There is a pressing need for the development of novel, specific biomarkers to improve the
detection and treatment of CIN and improve patient outcome in this high risk population.
This is a single centre,study in diabetic patients already undergoing a planned procedure,
that is, a percutaneous coronary intervention (PCI). They are patients who are deemed to
have an enhanced risk of contrast induced nephropathy by virtue of their diabetic and renal
status, the latter being defined by a reduced eGFR which is a marker of renal disease and is
based on the creatinine and characteristics of the patient. No additional interventions that
are not part of their routine clinical care will be undertaken in these patients. We will be
identifying natural biomarkers by obtaining serum and urine samples from these patients.
From a retrospective audit of the cardiac catheter lab database and a review of the
literature we have estimated that a sample size of approximately 250 patients with DM and
CKD (eGFR < 60 ml/ml) will be needed. We envisage that that we will encounter at least 50
cases of CIN from this cohort. (based on an expected incidence of CIN between 15−30% in this
group). Looking for a study rate difference of at least 25%, for power of 95% and confidence
intervals of 95% (with Fleiss correction) we will need at least 204 evaluable patients (to
avoid Type 2 error). In view of potential drop−out of 10−15% we therefore intend to recruit
250 patients By using C statistics (Receiver operator curve analysis) we will be able to
confirm or otherwise that either a particular biomarker or a combination of several
biomarkers within 18 hours of procedure will increase the predictive power of CIN developing
72 hours later.
As part of their normal care patients will arrive in hospital on the morning of their
planned PCI. They will at some point during the day undergo their PCI. Blood and urine will
be taken just prior to the procedure and then at 2 hours, 4 hours, 8 to 12 hours, pre
discharge and 3 days after the PCI.
We will then analyse the samples using ELISA techniques and correlate the biomarkers with
creatinine to explore which biomarkers or panel of biomarkers may be able to diagnose
contrast induced nephropathy earlier than creatinine can currently.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
| Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
| Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
| Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
| Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
| Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
| Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
| Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
| Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |