- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362112
Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes
April 12, 2022 updated by: Nanjing First Hospital, Nanjing Medical University
Lipoprotein-associated phospholipase A2 (LP-PLA2) is a good marker of cardiovascular risk and inflammation.
This study aims at the characteristic and clinical significance of LP-PLA2 test in patients with type 2 diabetes(T2D).
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators recorded clinical factors, serum levels of glucose, HbA1c, lipids and LP-PLA2 in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to August 2016.
The relationship between levels of LP-PLA2 and diabetic complications are analysed.
Study Type
Observational
Enrollment (Actual)
1713
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to August 2016 were enrolled in this study.
Description
Inclusion Criteria:
- Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.
Exclusion Criteria:
- Patients use systemic steroidal anti-inflammatory drugs.
- Patients are pregnant.
- Patients with an acute infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipoprotein-associated Phospholipase A2
Time Frame: Day one
|
the plasma lipoprotein-associated phospholipase A2 level of patients
|
Day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: Day one
|
the glycosylated hemoglobin level of patients
|
Day one
|
|
LDL-c
Time Frame: Day one
|
low density lipoprotein cholesterol
|
Day one
|
|
Diabetic Complication
Time Frame: Day one
|
the prevalence of atherosclerosis, diabetic Nephropathy, diabetic retinopathy and diabetic neuropathy
|
Day one
|
|
C Peptide
Time Frame: Day one
|
fast and 120min postprandial C peptide
|
Day one
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2015
Primary Completion (Actual)
August 31, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDO20171130-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.