Status:
UNKNOWN
Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes
Lead Sponsor:
Huazhong University of Science and Technology
Conditions:
Type 2 Diabetes
PreDiabetes
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
Although it has been suggested that selenium (Se) increases the risk of T2DM, most evidence comes from observational studies that cannot prove causality. A systematic review assessed randomized clinic...
Eligibility Criteria
Inclusion
- FPG ≥ 5.6 mmol/L;
- HbA1c ≥ 5.7%;
- OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L.
- T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior.
Exclusion
- Under 30 years old or above 70 years old;
- Pregnancy;
- Major surgery in the previous 6 months or planned to occur during the trail;
- Insulin injection for diabetes;
- Suffering from severe obesity (BMI \> 40 kg/m2), immunodeficiency syndrome, thyroid disease, coronary heart disease, stroke, malignant neoplasm, kidney or liver disease, or other serious diseases, such as mental illness;
- Reduced kidney function (GFR \< 60 mL/min/1.73m2, creatinine \> 1.2 times the normal upper limit \[male, \> 133.2 μmol/L; female \> 100 μmol/L\]);
- Systolic or diastolic blood pressure greater than 160 or 100 mmHg;
- Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention;
- Taking antibiotics or probiotics within 12 weeks of screening.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05320510
Start Date
October 1 2022
End Date
March 1 2023
Last Update
June 6 2022
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