RecruitingPhase 4NCT05835037

Effect of Zinc on Glucose Homeostasis

Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes


Sponsor

University of Maryland, Baltimore

Enrollment

200 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Zinc Gluconate 30 MG for people with hyperglycemia and prediabetic state. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZinc Gluconate 30 MG

Participants will take one tablet per day (30 mg Zinc gluconate) for 1 year

DRUGPlacebo

Participants will take one placebo tablet per day for 1 year


Locations(1)

Amish Research Clinic

Lancaster, Pennsylvania, United States

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NCT05835037


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