Progranulin induces autophagy disorder in type 2 diabetic nephropathy

• Register: ISRCTN
• Last refreshed on: 27 February 2017
• Main ID: ISRCTN18100534
• Date of registration: 03/02/2017
• Prospective Registration: No
• Primary sponsor: National Natural Science Foundation of China
• Public title: Progranulin induces autophagy disorder in type 2 diabetic nephropathy
• Scientific title: PGRN Links Autophagy: Etiology study of Type 2 diabetic nephropathy
• Date of first enrolment: 01/08/2014
• Target sample size: 154
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN18100534
• Study type: Observational
• Study design: Observational cohort study (Screening)

Countries of recruitment

Afghanistan

Contacts

• Name: Hongzhi Sun

Key inclusion & exclusion criteria

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

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.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic nephropathy
Urological and Genital Diseases
Diabetic nephropathy

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

2014074

Source(s) of Monetary Support

National Natural Science Foundation of China, The New Century Excellent Talentsin University from the Ministry of Education

Secondary Sponsor(s)

The New Century Excellent Talentsin University from the Ministry of Education