NCT05320510

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

Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes: a Double Blinded, Randomized Controlled Trail

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• PreDiabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Se-yeast	The participants will be asked to take Se-yeast tablet. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
DIETARY_SUPPLEMENT	Placebo	The participants will be asked to take placebo-yeast tablet. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-01-01
• Completion: 2023-03-01
• First posted: 2022-04-11
• Last updated: 2022-06-06