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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Se-yeast; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Se-yeast; Selenium-enriched yeast tablet (Se, 50 μg/d)	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.
Placebo Comparator: Placebo; placebo-yeast tablet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of HbA1c concentration	Change of glycated hemoglobin concentration	0 week, 4th week, 8th week, and 12th week in the intervention period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; prediabetes; selenium
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: LK20220322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No