Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes

Not Applicable

• Conditions: PreDiabetes; Type 2 Diabetes
• Interventions: Dietary Supplement: Se-yeast; Dietary Supplement: Placebo

• Registration Number: NCT05320510
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-02
• Study First Posted: 2022-04-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06
• Study Start: 2022-10-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Se-yeast	Se-yeast	Selenium-enriched yeast tablet (Se, 50 μg/d)
Placebo	Placebo	placebo-yeast tablet

Primary Outcome Measures

Name	Time	Method
Change of HbA1c concentration	0 week, 4th week, 8th week, and 12th week in the intervention period	Change of glycated hemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
Change of FPG concentration	0 week, 4th week, 8th week, and 12th week in the intervention period	Change of fasting plasma glucose concentration
Change of FPI concentration	0 week, 4th week, 8th week, and 12th week in the intervention period	Change of fasting plasma insulin concentration
Change of TG concentration	0 week, 4th week, 8th week, and 12th week in the intervention period	Change of serum triglyceride concentration
Change of TC concentration	0 week, 4th week, 8th week, and 12th week in the intervention period	Change of total cholesterol concentration
Change of HOMA-IR	0 week, 4th week, 8th week, and 12th week in the intervention period	Change of homeostasis model of assessment-insulin resistance