- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470454
Contrast Nephropathy in Type 2 Diabetes (VCG4)
Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria
Study Overview
Status
Intervention / Treatment
Detailed Description
Study design:
This study will be an observational prospective cohort study.
Study population:
Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors.
Data collection:
Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Fayoum, Egypt
- Fayoum university
-
Fayoum, Egypt
- Faculty of medicine Fayoum univesity
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diabetics on DPP 4 inhibitor treatment
Exclusion Criteria:
- Diabetics on insulin
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
diabetics on linagelptin
Diabetic patients were given linagelptin for blood glucose control
|
Linagliptin for blood glucose control
|
diabetics on other DPP4 inhibitors
Diabetic pateints were given other DPP4 inhibitors eg: vlidagliptin for blood glucose control
|
Linagliptin for blood glucose control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
affection of estimated glomerular filtration rate
Time Frame: Two months
|
A significant decrease in estimated glomerular filtration rate (eGFR)
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in serum uric acid
Time Frame: Two months
|
A significant rise in serum uric acid
|
Two months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affection of albumin creatinine ratio
Time Frame: Two months
|
A significant increase in albumin creatinine ratio in urine (ACR)
|
Two months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Usama A Sharafeldin, MD, Cairo University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
Other Study ID Numbers
- VCG 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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