Effect of Zinc on Glucose Homeostasis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Maryland, Baltimore

About this trial

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 criteria

Qualifiers

Amish men or women who are 18 to 80 years old

Prediabetes (HgbA1c = 5.7-6.4% or fasting glucose levels 100-125 mg/dL)

Disqualifiers

Pregnant

Currently breastfeeding

History of severe gastrointestinal disorders or upper gastrointestinal surgery

Has hemochromatosis, cancer, liver disease, kidney disease, cardiovascular disease, or other coexisting malignancy

Trial design

Treatments tested in this trial

  • Zinc Gluconate 30 MG
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

1
Amish Research Clinic17602, LancasterPennsylvania, United States

Sponsors and collaborators

University of Maryland, Baltimore

Lead sponsor