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Effect of Zinc on Glucose Homeostasis
Sponsor: University of Maryland, Baltimore
Summary
The purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo. Specific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \[mg\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.
Official title: Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-02-16
Completion Date
2028-07
Last Updated
2025-04-23
Healthy Volunteers
No
Conditions
Interventions
Zinc Gluconate 30 MG
Participants will take one tablet per day (30 mg Zinc gluconate) for 1 year
Placebo
Participants will take one placebo tablet per day for 1 year
Locations (1)
Amish Research Clinic
Lancaster, Pennsylvania, United States