Actively Recruiting
Effect of Zinc on Glucose Homeostasis
Led by University of Maryland, Baltimore · Updated on 2026-05-05
200
Participants Needed
1
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Zinc on Glucose Homeostasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Amish men or women aged 18 to 80 years
- Diagnosed with prediabetes (HbA1c between 5.7% and 6.4% or fasting glucose levels between 100 and 125 mg/dL)
You will not qualify if you...
- Pregnant or currently breastfeeding
- History of severe gastrointestinal disorders or upper gastrointestinal surgery
- Diagnosis of hemochromatosis, cancer, liver disease, kidney disease, cardiovascular disease, or other malignancies
- Hemoglobin less than 12.5 g/dl for males or less than 11 g/dl for females
- Severe hypertension with blood pressure over 160/95 mm Hg
- Creatinine level greater than 2.0 mg/dl
- Elevated liver enzymes (AST or ALT more than twice the upper limit of normal)
- Hematocrit less than 32%
- Thyroid-stimulating hormone (TSH) levels less than 0.4 or greater than 5.5 mIU/L
- Taking medications affecting study outcomes, including corticosteroids, antipsychotics, protease inhibitors, oral contraceptives, estrogens, niacin, certain antidepressants, statins, or antihypertensives
- Hypersensitivity to zinc
- Use of denture adhesive containing zinc
- Taking other medications or zinc supplements and unable or unwilling to stop them safely at least 2 weeks before starting the study
- Any other condition deemed by the investigator to pose unacceptable risk or prevent meeting study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amish Research Clinic
Lancaster, Pennsylvania, United States, 17602
Actively Recruiting
Research Team
J
Joshua P Lewis, PhD
CONTACT
H
Hilary B Whitlatch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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