Investigating the levels of extrachromosomal circular DNA in serum of newly diagnosed type 2 diabetes mellitus patients
| ISRCTN | ISRCTN12415732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12415732 |
- Submission date
- 07/12/2020
- Registration date
- 21/12/2020
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims：
Extrachromosomal circular DNA (eccDNA) has long been known to form from proto-oncogenes which are normal genes present in the human genome which, when altered by mutation, can become a gene that can contribute to cancer (an oncogene). The formation of eccDNA has also been linked to aging.
The levels of eccDNA circulating in the body outside of cells in type 2 diabetes patients have not previously been investigated. The aim of this study is to assess the levels of serum of eccDNA in newly diagnosed type 2 diabetes patients.
Who can participate?
Newly diagnosed type 2 diabetes patients and healthy volunteers.
What does the study involve?
Participants will provide blood samples which will be tested to find eccDNA that are present at high or low levels in newly diagnosed type 2 diabetes.
What are the possible benefits and risks of participating?
There is no direct benefit to the participant by taking part in this study. Data collected may be used to support future clinical studies in this population.
There are no risks of participating in this study. Participants will receive treatment for their illness that follows the National Chinese guidelines for treating this type of illness.
Where is the study run from?
The First Affiliated Hospital of Wannan Medical College, Yijishan Hospital (China)
When is the study starting and how long is it expected to run for?
From May 2020 to May 2021
Who is funding the study?
The National Natural Science Foundation of China (China) and "Peak" Training Program for Scientific Research of Yijishan Hospital, Wannan Medical College (China)
Who is the main contact?
Prof. Xiang Kong
wnmcyaolikx@sina.com
Contact information
Scientific
Key Laboratory of Noncoding RNA Transformation Research of Anhui Higher Education Institution Wannan Medical College
Wuhu
241001
China
 ORCID ID |
0000-0003-1734-5171 |
|---|---|
| Phone | +86 5739856 |
| wnmcyaolikx@sina.com |
Study information
| Study design | Observational study of cases and controls |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pilot study to assess abnormal expression of serum extrachromosomal circular DNA between newly diagnosed type 2 diabetes mellitus patients and healthy participants. |
| Study objectives | To determine the abnormal expression of cell-free circulating extrachromosomal circular DNA in newly diagnosed type 2 diabetes mellitus patients. |
| Ethics approval(s) | Approved 20/07/2020, Scientific Research and New Technology Ethics Committee of Wannan Medical College Yijishan Hospital (2 Zheshanxi Rd, Wuhu, 241001, China; +86 (0)5535939912; lvkun315@126.com), ref: 2020022 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Peripheral blood samples will be collected from newly diagnosed type 2 diabetes mellitus patients and healthy participants. Serum DNA extractions were performed using QIAamp Circulating Nucleic Acid Kit (Qiagen). For elimination of linear DNA and enrichment of eccDNA, 25 ng of plasma/serum DNA will be treated with 5 units of Plasmid-Safe ATP-dependent DNase (Epicentre) in a 50 μl reaction system at 37°C for 5 min, followed by column purification using MinElute Reaction Cleanup Kit (Qiagen). EccDNA enriched from 25 ng of plasma/serum DNA will be processed using Nextera XT DNA Library Preparation Kit (Illumina). DNA libraries will be sequenced on Illumina NovaSeq 6000 with 150 bp paired end mode according to the manufacturer’s instructions. Real-time PCR will be used to verify the differentially expressed eccDNA candidates. The correlation between the differentially expressed eccDNA and other clinical factors will also be evaluated. |
| Intervention type | Other |
| Primary outcome measure | 1. Serum eccDNA levels in peripheral blood samples of newly diagnosed type 2 diabetes mellitus patients measured using high throughput sequencing at the time of data collection |
| Secondary outcome measures | 1. Clinical factors associated with the differentially expressed eccDNA measured using patient records at the time of data collection |
| Overall study start date | 01/05/2020 |
| Completion date | 01/07/2021 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 newly diagnosed type 2 diabetes mellitus patients and 12 healthy volunteers |
| Total final enrolment | 146 |
| Key inclusion criteria | 1. Type 2 diabetes mellitus diagnosed according to the 1999 World Health Organization diagnostic criteria |
| Key exclusion criteria | 1. No clinical evidence of severe kidney or liver diseases, chronic viral or bacterial infection, inflammatory diseases, tumors, or diabetic ketoacidosis |
| Date of first enrolment | 21/07/2020 |
| Date of final enrolment | 01/03/2021 |
Locations
Countries of recruitment
- China
Study participating centre
2 Zheshanxi Rd
Wuhu
241001
China
Sponsor information
University/education
2 Zheshanxi Rd
Yijishan Hospital
Wuhu
241001
China
| Phone | +86 5739912 |
|---|---|
| lvkun315@126.com | |
| Website | https://www.yjsyy.com/ |
"ROR" |
https://ror.org/037ejjy86 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/01/2024 | 21/01/2025 | Yes | No |
Editorial Notes
21/01/2025: Publication reference and total final enrolment added.
14/12/2020: Trial’s existence confirmed by Scientific Research and New Technology Ethics Committee of Wannan Medical College Yijishan Hospital.
