NCT05835037 Effect of Zinc on Glucose Homeostasis
| NCT ID | NCT05835037 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Prediabetic State |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-02-16 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 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 transaminase (ALT) greater than 2 times the upper limit of normal, hematocrit (Hct) less than 32%, or thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 milli-international units (mIU) per liter. * 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.
Contact & Investigator
Joshua P Lewis, PhD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT05835037 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Prediabetic State. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05835037 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05835037 currently recruiting?
Yes, NCT05835037 is actively recruiting participants. Contact the research team at jlewis2@som.umaryland.edu for enrollment information.
Where is the NCT05835037 trial being conducted?
This trial is being conducted at Lancaster, United States.
Who is sponsoring the NCT05835037 clinical trial?
NCT05835037 is sponsored by University of Maryland, Baltimore. The principal investigator is Joshua P Lewis, PhD at University of Maryland, Baltimore. The trial plans to enroll 200 participants.