Type2 DiabetesNCT03362112

Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes

An observational study of Type2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Any age
Conditions the study is for: Type2 Diabetes
How many people: 1,713 participants
Where: No sites listed yet
Study dates: 30 Jan 2015to 1 Jun 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

About this study

Read the 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.

Conditions: Type2 Diabetes
Keywords: lipoprotein-associated phospholipase A2

What is being measured

The primary outcome is the main question the study is designed to answer.

Lipoprotein-associated Phospholipase A2
the plasma lipoprotein-associated phospholipase A2 level of patients
Measured: Day one

Secondary outcomes (4)

HbA1c
the glycosylated hemoglobin level of patients
Measured: Day one
LDL-c
low density lipoprotein cholesterol
Measured: Day one
Diabetic Complication
the prevalence of atherosclerosis, diabetic Nephropathy, diabetic retinopathy and diabetic neuropathy
Measured: Day one
C Peptide
fast and 120min postprandial C peptide
Measured: Day one

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 20151 Jun 2017

First posted5 Dec 2017
Study start30 Jan 2015
Primary completion31 Aug 2016
Study completion1 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type2 DiabetesStudies of the same condition, open and under way.
More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
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: Retrospective
Enrolment: 1,713 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03362112
Sponsor's protocol ID: ENDO20171130-1
Status last verified: Nov 2017
First submitted: 29 Nov 2017
Last updated: 14 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hu Y, Li TT, Zhou W, Lu TT, Li FF, Ding B, Liu BL, Xie XJ, Ma JH. Lipoprotein-associated phospholipase A2 is a risk factor for diabetic kidney disease. Diabetes Res Clin Pract. 2019 Apr;150:194-201. doi: 10.1016/j.diabres.2019.03.026. Epub 2019 Mar 20.
PubMed 30904742

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT03362112
Acronym / sponsor ID: ENDO20171130-1
Conditions: Type2 Diabetes
Keywords: lipoprotein-associated phospholipase A2
Study type: Observational
Recruitment status: Completed
Enrolment: 1,713 participants (actual)
Lead sponsor: Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
Study start: 30 Jan 2015 (actual)
Primary completion: 31 Aug 2016 (actual)
Study completion: 1 Jun 2017 (actual)
First posted: 5 Dec 2017 (actual)
Results: Posted 14 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Lipoprotein-associated Phospholipase A2
Time frame: Day one
the plasma lipoprotein-associated phospholipase A2 level of patients

4 secondary outcomes

HbA1c
Time frame: Day one
LDL-c
Time frame: Day one
Diabetic Complication
Time frame: Day one
C Peptide
Time frame: Day one

Results and safety

Results posted to the registry on 14 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With T2DM	1,713	1,622

Primary outcome: Lipoprotein-associated Phospholipase A2

Time frame: Day one. Mean (Standard Deviation). Unit: ng/ml

Measure	Patients With T2DM n = 1452
Value	238.4 (111.9)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With T2DM	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30904742Hu Y, Li TT, Zhou W, Lu TT, Li FF, Ding B, Liu BL, Xie XJ, Ma JH. Lipoprotein-associated phospholipase A2 is a risk factor for diabetic kidney disease. Diabetes Res Clin Pract. 2019 Apr;150:194-201. doi: 10.1016/j.diabres.2019.03.026. Epub 2019 Mar 20.

Related trials for Type2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University.

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 1 inclusion and 3 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 14 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Lipoprotein-associated Phospholipase A2 (time frame: Day one). 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 NCT03362112, which also lists 1 linked publication.

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 14 Apr 2022.