Effects of Zinc Supplementation on Patients With Elevated Glycemic Status

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhilei Shan

About this trial

The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fasting blood glucose ≥ 6.1 mmol /L;

HBA1c ≥ 5.7%;

OGTT 2-hour or postprandial blood glucose ≥ 7.8 mmol/L;

Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.

Disqualifiers

Age < 18 years, or currently pregnant;

Individuals with severe obesity, thyroid disease, cardiovascular or cerebrovascular diseases, or other serious health conditions;

Individuals with a previous diagnosis of type 2 diabetes currently receiving insulin therapy;

Individuals who have taken zinc-related supplements within three months prior to baseline inclusion;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zinc-enriched yeast capsule

    Dietary supplement

    Daily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months.

  • Edible yeast placebo capsule

    Dietary supplement

    Daily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Zinc supplementationExperimental treatment 1 intervention
Group B: Edible yeast placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of fasting blood glucose (FBG)

Concentration of FBG, measured in mmol/L

Time frame
0 week, 12th week, and 24th week in the intervention period
2

Glycated hemoglobin (HbA1c)

Concentration of HbA1c, measured in the percentage of hemoglobin

Time frame
0 week, 12th week, and 24th week in the intervention period

Secondary outcomes

1

Concentration of fasting plasma insulin (FPI)

Concentration of FPI, measured in μIU/mL

Time frame
0 week, 12th week, and 24th week in the intervention period
2

Concentration of plasma c-peptide

Concentration of plasma c-peptide, measured in nmol/L

Time frame
0 week, 12th week, and 24th week in the intervention period
3

Homeostatic model assessment of insulin resistance (HOMA-IR)

HOMA-IR can be calculated as (FPI \[μU/mL\] × FBG \[mmol/L\]) / 22.5

Time frame
0 week, 12th week, and 24th week in the intervention period
4

Homeostatic model assessment of β-cell function (HOMA-β)

HOMA-β is calculated as (20 × FPI \[μU/mL\]) / (FBG \[mmol/L\] - 0.195)

Time frame
0 week, 12th week, and 24th week in the intervention period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhilei Shan

Lead sponsor

Huazhong University of Science and Technology

Sponsor institution

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