Effect of Zinc on Glucose Homeostasis

Part of paid clinical trials in Lancaster, Pennsylvania.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05835037
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hyperglycemia
  • Prediabetic State

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Zinc Gluconate 30 MG — DRUG
    Participants will take one tablet per day (30 mg Zinc gluconate) for 1 year
  • Placebo — DRUG
    Participants will take one placebo tablet per day for 1 year

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Zinc treatment
    Research subjects administered zinc gluconate for 1 year (one 30 mg tablet per day)
  • Placebo Comparator: Placebo
    Research subjects administered placebo for 1 year (1 tablet per day)

Primary Outcome Measure

Zinc-dependent effect on fasting glucose levels at 1 year [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Amish Research ClinicLancasterPennsylvania17602
Kamah Woelfel, RN
[email protected]
717-392-4948

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By research site
Amish Research Clinic· Lancaster, PA

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