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Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes

Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03362112
Enrollment
1713
Registered
2017-12-05
Start date
2015-01-30
Completion date
2017-06-01
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Keywords

lipoprotein-associated phospholipase A2

Brief summary

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).

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.

Interventions

None listed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.

Exclusion criteria

1. Patients use systemic steroidal anti-inflammatory drugs. 2. Patients are pregnant. 3. Patients with an acute infection.

Design outcomes

Primary

MeasureTime frameDescription
Lipoprotein-associated Phospholipase A2Day onethe plasma lipoprotein-associated phospholipase A2 level of patients

Secondary

MeasureTime frameDescription
HbA1cDay onethe glycosylated hemoglobin level of patients
LDL-cDay onelow density lipoprotein cholesterol
Diabetic ComplicationDay onethe prevalence of atherosclerosis, diabetic Nephropathy, diabetic retinopathy and diabetic neuropathy
C PeptideDay onefast and 120min postprandial C peptide

Participant flow

Participants by arm

ArmCount
Patients With T2DM
Patients with type 2 diabetes
1,713
Total1,713

Baseline characteristics

CharacteristicPatients With T2DM
Age, Continuous58.5 years
STANDARD_DEVIATION 12.5
Race and Ethnicity Not Collected— Participants
Region of Enrollment
China
1713 Participants
Sex: Female, Male
Female
658 Participants
Sex: Female, Male
Male
1055 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Lipoprotein-associated Phospholipase A2

the plasma lipoprotein-associated phospholipase A2 level of patients

Time frame: Day one

ArmMeasureValue (MEAN)Dispersion
Patients With T2DMLipoprotein-associated Phospholipase A2238.4 ng/mlStandard Deviation 111.9
Secondary

C Peptide

fast and 120min postprandial C peptide

Time frame: Day one

Secondary

Diabetic Complication

the prevalence of atherosclerosis, diabetic Nephropathy, diabetic retinopathy and diabetic neuropathy

Time frame: Day one

Secondary

HbA1c

the glycosylated hemoglobin level of patients

Time frame: Day one

ArmMeasureValue (MEAN)Dispersion
Patients With T2DMHbA1c9.1 percentage of glycated hemoglobinStandard Deviation 2.1
Secondary

LDL-c

low density lipoprotein cholesterol

Time frame: Day one

ArmMeasureValue (MEAN)Dispersion
Patients With T2DMLDL-c2.5 mmol/LStandard Deviation 0.8

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026