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Effect of Zinc on Glucose Homeostasis

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Study description expanded, about 1 wordv7
  3. Re-verified, no change to tracked fieldsv6
  4. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date changed from estimate of Apr 2024 to Feb 16, 2024
    • Interventions: Placebo (Drug), Zinc Acetate 25 MG (Drug) to Placebo (Drug), Zinc Gluconate 30 MG (Drug)
    • Study description expanded, about 1,111 words
    • Site details revised
  5. Start date: Dec 2023 to Apr 2024v4
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  1. Start date: Jul 2023 to Dec 2023v3
  2. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study title expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05835037
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)		 Prediabetic State, Hyperglycemia
Related terms Hyperglycemia, Prediabetic State
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov