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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05320510
• Other study ID #: LK20220322
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2022
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1c concentration	Change of glycated hemoglobin concentration	0 week, 4th week, 8th week, and 12th week in the intervention period
Secondary	Change of FPG concentration	Change of fasting plasma glucose concentration	0 week, 4th week, 8th week, and 12th week in the intervention period
Secondary	Change of FPI concentration	Change of fasting plasma insulin concentration	0 week, 4th week, 8th week, and 12th week in the intervention period
Secondary	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
Secondary	Change of TG concentration	Change of serum triglyceride concentration	0 week, 4th week, 8th week, and 12th week in the intervention period
Secondary	Change of TC concentration	Change of total cholesterol concentration	0 week, 4th week, 8th week, and 12th week in the intervention period