Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes
University of Maryland, Baltimore
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.
Description
Subjects: 200 prediabetic, but otherwise healthy, subjects will be recruited at the Amish Research Clinic in Lancaster, Pennsylvania (PA). Recruitment of individuals with prediabetes will be facilitated through prior measurements of HbA1c (5.7 to 6.4%), or fasting blood glucose levels (100 to 125 mg/dL) if HbA1c is unavailable for a given participant, and current prediabetes status will be confirmed during eligibility screening. Study Design and Intervention: 200 prediabetic subjects will be randomized 1:1 to either zinc gluconate (30 mg/day by mouth) or placebo for 12 months. Zinc dose and d…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Hemoglobin \< 12.5 g/dl (male) or \< 11 g/dl (female) * Severe hypertension (blood pressure \> 160/95 mm Hg) * Has a creatinine greater than 2.0 mg/dl, aspartate aminotransferase (AST) or alanine tr…
Interventions
- DrugZinc Gluconate 30 MG
Participants will take one tablet per day (30 mg Zinc gluconate) for 1 year
- DrugPlacebo
Participants will take one placebo tablet per day for 1 year
Location
- Amish Research ClinicLancaster, Pennsylvania