Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes

NCT05835037 Phase 4 RECRUITING

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.

Details

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 4
Status	RECRUITING
Enrolment	200
Start date	2024-02-16
Completion	2028-07

Conditions

• Prediabetic State
• Hyperglycemia

Interventions

• Zinc Gluconate 30 MG
• Placebo

Primary outcomes

• Zinc-dependent effect on fasting glucose levels at 1 year — 1 year
  One of the investigator's primary endpoints will be to determine the difference in fasting glucose levels between zinc-treated and placebo-treated individuals after 1 year of receiving study drug
• Zinc-dependent effect on HbA1c at 1 year — 1 year
  One of the investigator's primary endpoints will be to determine the difference in HbA1c levels between zinc-treated and placebo-treated individuals after 1 year of receiving study drug

Countries

United States