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

Primary Purpose

Type 2 Diabetes, PreDiabetes

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Se-yeast

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring selenium, Type 2 Diabetes, prediabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Under 30 years old or above 70 years old;
Pregnancy;
Major surgery in the previous 6 months or planned to occur during the trail;
Insulin injection for diabetes;
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;
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]);
Systolic or diastolic blood pressure greater than 160 or 100 mmHg;
Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention;
Taking antibiotics or probiotics within 12 weeks of screening.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Se-yeast

Placebo

Arm Description

Selenium-enriched yeast tablet (Se, 50 μg/d)

placebo-yeast tablet

Outcomes

Primary Outcome Measures

Change of HbA1c concentration

Change of glycated hemoglobin concentration

Secondary Outcome Measures

Change of FPG concentration

Change of fasting plasma glucose concentration

Change of FPI concentration

Change of fasting plasma insulin concentration

Change of HOMA-IR

Change of homeostasis model of assessment-insulin resistance

Change of TG concentration

Change of serum triglyceride concentration

Change of TC concentration

Change of total cholesterol concentration

Full Information

NCT ID

NCT05320510

First Posted

March 22, 2022

Last Updated

June 1, 2022

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT05320510

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2022 (Anticipated)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, PreDiabetes

Keywords

selenium, Type 2 Diabetes, prediabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Se-yeast

Arm Type

Experimental

Arm Description

Selenium-enriched yeast tablet (Se, 50 μg/d)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo-yeast tablet

Intervention Type

Dietary Supplement

Intervention Name(s)

Se-yeast

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of HbA1c concentration

Description

Change of glycated hemoglobin concentration

Time Frame

0 week, 4th week, 8th week, and 12th week in the intervention period

Secondary Outcome Measure Information:

Title

Change of FPG concentration

Description

Change of fasting plasma glucose concentration

Time Frame

0 week, 4th week, 8th week, and 12th week in the intervention period

Title

Change of FPI concentration

Description

Change of fasting plasma insulin concentration

Time Frame

0 week, 4th week, 8th week, and 12th week in the intervention period

Title

Change of HOMA-IR

Description

Change of homeostasis model of assessment-insulin resistance

Time Frame

0 week, 4th week, 8th week, and 12th week in the intervention period

Title

Change of TG concentration

Description

Change of serum triglyceride concentration

Time Frame

0 week, 4th week, 8th week, and 12th week in the intervention period

Title

Change of TC concentration

Description

Change of total cholesterol concentration

Time Frame

0 week, 4th week, 8th week, and 12th week in the intervention period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: FPG ≥ 5.6 mmol/L; HbA1c ≥ 5.7%; OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L. T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior. Exclusion Criteria: Under 30 years old or above 70 years old; Pregnancy; Major surgery in the previous 6 months or planned to occur during the trail; Insulin injection for diabetes; 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; 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]); Systolic or diastolic blood pressure greater than 160 or 100 mmHg; Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention; Taking antibiotics or probiotics within 12 weeks of screening.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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