Investigating how gene mutations affect diabetes susceptibility in patients
Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
This study is testing how certain gene changes might affect the risk of developing Type 2 Diabetes in newly diagnosed patients compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University Academic / other |
| Locations | 1 site (Xuzhou) |
| Trial ID | NCT06277466 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of mutations in susceptibility genes associated with Type 2 Diabetes Mellitus (T2DM) on the expression of these genes in both T2DM patients and healthy controls. Participants will include newly diagnosed T2DM patients and healthy subjects, from whom fresh blood samples and pancreatic tissues will be collected. The study will analyze the expression levels of various T2DM susceptibility genes using techniques such as ELISA, PCR, and immunohistochemistry. Additionally, the research will compare gene expression differences among participants with varying genotypes and assess their relationship with clinical characteristics.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed T2DM patients aged 25 to 70 years and healthy individuals aged 25 to 60 years without any significant health issues.
Not a fit: Patients who have previously taken antidiabetic drugs or have a history of pancreatic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of genetic factors influencing T2DM, potentially leading to improved prevention and treatment strategies.
How similar studies have performed: While the investigation of genetic mutations in relation to T2DM is an established area, the specific approach of this study may provide novel insights into gene expression dynamics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）. 2. 25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）. 3. 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）. Exclusion Criteria: 1. had taken antidiabetic drugs; 2. had a history of pancreatic surgery; 3. Complicated with severe organ lesions; 4. Long-term use of drugs that affect pancreatic function.
Where this trial is running
Xuzhou
- China, Jiangsu, Department of Endocrinology — Xuzhou, China (Recruiting)
Study contacts
- Study coordinator: Tao Wang, Ph.D
- Email: misswt2011@126.com
- Phone: 13815344640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.