Clinical trial NCT05320510: Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes
Official title: Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes: a Double Blinded, Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Keywords: selenium
Type 2 Diabetes
prediabetes
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 clinical trials and found that the risk of T2DM was not greater in those randomized to Se supplementation than in those randomized to placebo. Se is a toxic element in animals and humans, and overexposure to Se has also been linked to detrimental health effects in humans. Previous studies were mostly conducted in Se-sufficient areas. Moreover, the effectiveness of low-dose Se supplementation on participants with elevated glycemic status was unknown. This cross-over, double blinded, randomized controlled trail aimed to investigate the effectiveness of Se supplementation for glucose control among participants with diabetes or prediabetes. Moreover, we also aimed to examine whether selenoprotein P genotypes, Se-related gut microbiota and their related metabolite modified the effectiveness.


Eligibility criteria: Inclusion Criteria:

1. FPG ≥ 5.6 mmol/L;
2. HbA1c ≥ 5.7%;
3. OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L.
4. T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior.

Exclusion Criteria:

1. Under 30 years old or above 70 years old;
2. Pregnancy;
3. Major surgery in the previous 6 months or planned to occur during the trail;
4. Insulin injection for diabetes;
5. 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;
6. Reduced kidney function (GFR \< 60 mL/min/1.73m2, creatinine \> 1.2 times the normal upper limit \[male, \> 133.2 μmol/L; female \> 100 μmol/L\]);
7. Systolic or diastolic blood pressure greater than 160 or 100 mmHg;
8. Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention;
9. Taking antibiotics or probiotics within 12 weeks of screening.

Primary outcomes:
measure: Change of HbA1c concentration
timeFrame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Secondary outcomes:
measure: Change of FPG concentration
timeFrame: 0 week, 4th week, 8th week, and 12th week in the intervention period
measure: Change of FPI concentration
timeFrame: 0 week, 4th week, 8th week, and 12th week in the intervention period
measure: Change of HOMA-IR
timeFrame: 0 week, 4th week, 8th week, and 12th week in the intervention period
measure: Change of TG concentration
timeFrame: 0 week, 4th week, 8th week, and 12th week in the intervention period
measure: Change of TC concentration
timeFrame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Other outcomes:
Locations:
Study officials:
References: