NCT05320510

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable type-2-diabetes

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

March 22, 2022

Last Update Submit

June 1, 2022

Conditions

Type 2 DiabetesPreDiabetes

Keywords

seleniumType 2 Diabetesprediabetes

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1c concentration

    Change of glycated hemoglobin concentration

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

Secondary Outcomes (5)

  • Change of FPG concentration

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

  • Change of FPI concentration

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

  • Change of HOMA-IR

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

  • Change of TG concentration

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

  • Change of TC concentration

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

Study Arms (2)

Se-yeast

EXPERIMENTAL

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

Dietary Supplement: Se-yeast

Placebo

PLACEBO COMPARATOR

placebo-yeast tablet

Dietary Supplement: Placebo

Interventions

Se-yeastDIETARY_SUPPLEMENT

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.

Se-yeast
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 11, 2022

Study Start

October 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

June 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share