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RECRUITING
NCT05835037
PHASE4

Effect of Zinc on Glucose Homeostasis

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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

Interventions

DRUG

Zinc Gluconate 30 MG

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

DRUG

Placebo

Participants will take one placebo tablet per day for 1 year

Locations (1)

Amish Research Clinic

Lancaster, Pennsylvania, United States