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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list