Condition category
Urological and Genital Diseases
Date applied
15/01/2017
Date assigned
03/02/2017
Last edited
02/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes (T2DM). Progranulin (PGRN) is a protein which has recently been found to play a role in regulating the breakdown of sugar in the body and the sensitivity of cells to insulin. However there is little known about the role PGRN plays in the development of diabetic nephropathy in people with T2DM. The aim of this study is to investigate the clinical significance and role of PGRN in people with T2DM.

Who can participate?
Adults with T2DM and adults who have normal blood sugar control.

What does the study involve?
All participants attend a single study visit where they have samples of blood taken in order to measure PGRN, blood sugar and insulin levels. Of these participants those who have kidney disease also have small samples taken from their kidneys (biopsy) to look at chemicals indicating cell breakdown.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small risk of complications such as infection for patients having samples of their kidneys taken.

Where is the study run from?
The First Affiliated Hospital of Xi’an Jiaotong University School of Medicine (China)

When is the study starting and how long is it expected to run for?
March 2013 to August 2016

Who is funding the study?
1. National Natural Science Foundation of China (China)
2. The New Century Excellent Talentsin University from the Ministry of Education (China)

Who is the main contact?
Professor Honzhi Sun
sunhongzhi@mail.xjtu.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hongzhi Sun

ORCID ID

Contact details

Medical School of Xi’an Jiaotong University
76 Yanta West Road
Xi’an
710061
China
+86 29 0826 55046
sunhongzhi@mail.xjtu.edu.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2014074

Study information

Scientific title

PGRN Links Autophagy: Etiology study of Type 2 diabetic nephropathy

Acronym

Study hypothesis

The aim of this study is to investigate the clinical significance and correlations of progranulin (PGRN) and autophagic imbalance in patients with type 2 diabetic nephropathy.

Ethics approval

Xi’an Jiao Tong University Ethics Committee, 01/03/2014, ref: 2014074

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetic nephropathy

Intervention

A total of 134 patients with type 2 diabetes and 20 participants with normal glucose tolerance are enrolled. Patients with type 2 diabetes are divided into three groups based on their urinary albumin excretion rate (UAER): simple diabetes mellitus (SDM), early diabetic nephropathy (EDN), and clinical diabetic nephropathy (CDN).

All participants one study visit and provide blood samples when they visit to measure serum PGRN, plasma glucose, plasma insulin and HbA1c. Serum concentrations of PGRN are measured using ELISA.

Renal tissue is obtained from six living allograft donors and 12 diabetic nephropathy patients (taken from the existing participant groups). Autophagy indicators Atg7, LC3, and p62 of renal tissue are detected by Real-time PCR and western blotting.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. PGRN serum concentration is measured using ELISAs at baseline and 2 hours after overnight fasting
2. Plasma glucose is measured using glucose oxidase method at baseline and 2 hours after overnight fasting
3. Serum insulin is measured using radioimmunoassay at baseline and 2 hours after overnight fasting
4. HbA1c values are measured using high-performance liquid chromatography at baseline and 2 hours after overnight fasting

Secondary outcome measures

Autophagy indicators Atg7, LC3, and p62 of renal tissue are measured using immunohistochemical examination, real-time PCR and western blotting at baseline, 0, 10, 20 and 40 minutes after overnight fasting.

Overall trial start date

03/03/2013

Overall trial end date

01/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Aged between 20 and 80 years old
2. Diagnosed with type 2 diabetes mellitus

Controls:
1. Aged between 32 and 72 years
2. Normal glucose control

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

154

Participant exclusion criteria

1. Past history of malignancy
2. Degenerative disease of the nervous system
3. Diabetic macrovascular complications
4. Other endocrine diseases which affect glucose metabolism and lipid metabolism
5. Chronic hepatitis
6. Primary kidney disease
7. Recent inflammatory disease
8. Acute trauma
9. Taking thiazolidinedione drugs in the previous 3 weeks
10. Pregnancy
11. History of drug abuse.

Recruitment start date

01/08/2014

Recruitment end date

01/08/2015

Locations

Countries of recruitment

Afghanistan

Trial participating centre

The First Affiliated Hospital of Xi’an Jiaotong University School of Medicine
Key Laboratory of Environment and Genes Related to Diseases Ministry of Education Medical School of Xi’an Jiaotong University
Xi’an
710061
China

Sponsor information

Organisation

National Natural Science Foundation of China

Sponsor details

Medical School of Xi’an Jiaotong University
76 Yanta West Road
Xi’an
710061
China
+86 02 90 8265 5046
sunhongzhi@mail.xjtu.edu.cn

Sponsor type

Government

Website

Organisation

The New Century Excellent Talentsin University from the Ministry of Education

Sponsor details

Medical School of Xi’an Jiaotong University
76 Yanta West Road
Xi’an
710061
China
+86 29 0826 55046
sunhongzhi@mail.xjtu.edu.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Natural Science Foundation of China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The New Century Excellent Talentsin University from the Ministry of Education

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Lin Xu (irenewayne@126.com)

Intention to publish date

01/08/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes