Zinc Supplementation in Prediabetes

• Status: Not yet recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: All

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. We 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 acetate 25 mg/day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, we 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore

Criteria

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 GI 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 (BP > 160/95 mm Hg)

• Has a creatinine greater than 2.0 mg/dl, AST or ALT greater than 2 times the upper limit of normal, Hct less than 32%, or a TSH less than 0.4 or greater than 5.5 mIU/L

• At the discretion of the study physician or PI, taking medications that affect the outcomes of the study including, but not limited to, corticosteroids, anti-psychotic agents, protease inhibitors, oral contraceptives, estrogens, niacin, and some classes of antidepressants, statins, and antihypertensive medications

• Zinc hypersensitivity

• Use of denture adhesive containing zinc

• Taking other medications or zinc-containing supplements and is unwilling or cannot safely, in the opinion of the study physician, discontinue their use at least 2 weeks prior to protocol initiation

• Any other condition that would, in the opinion of the investigator, place them at an unacceptable risk or render them unable to meet the requirements of the protocol.