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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Zinc-enriched yeast capsule
Dietary supplementDaily zinc supplementation: zinc-enriched yeast capsules (15 mg) for a total of 6 months.
Edible yeast placebo capsule
Dietary supplementDaily edible yeast placebo capsules (not zinc-enriched) (15 mg) for a total of 6 months.
Treatment groups
Trial outcomes
Primary outcomes
Concentration of fasting blood glucose (FBG)
Concentration of FBG, measured in mmol/L
Glycated hemoglobin (HbA1c)
Concentration of HbA1c, measured in the percentage of hemoglobin
Secondary outcomes
Concentration of fasting plasma insulin (FPI)
Concentration of FPI, measured in μIU/mL
Concentration of plasma c-peptide
Concentration of plasma c-peptide, measured in nmol/L
Homeostatic model assessment of insulin resistance (HOMA-IR)
HOMA-IR can be calculated as (FPI \[μU/mL\] × FBG \[mmol/L\]) / 22.5
Homeostatic model assessment of β-cell function (HOMA-β)
HOMA-β is calculated as (20 × FPI \[μU/mL\]) / (FBG \[mmol/L\] - 0.195)
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
This trial is not recruiting at the moment. You can still explore other options: