Zinc supplementation's effect on blood sugar levels in prediabetics
Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes
This study is testing if taking zinc supplements can help lower blood sugar levels in people with prediabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Lancaster, Pennsylvania) |
| Trial ID | NCT05835037 on ClinicalTrials.gov |
What this trial studies
This investigation evaluates the impact of zinc supplementation on glucose homeostasis in individuals with prediabetes. The study involves a prospective, double-blind, randomized design where 200 prediabetic subjects will be assigned to receive either zinc gluconate (30 mg/day) or a placebo for 12 months. Key measures such as fasting glucose levels and hemoglobin A1c (HbA1c) will be assessed at baseline, 6 months, and 12 months to determine the efficacy of zinc in lowering blood sugar levels. The study aims to provide insights into the potential role of zinc in managing prediabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are Amish men and women aged 18 to 80 who have been diagnosed with prediabetes.
Not a fit: Patients with severe gastrointestinal disorders, certain chronic diseases, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, accessible method for managing blood sugar levels in prediabetic patients.
How similar studies have performed: While the specific approach of zinc supplementation in prediabetes is novel, previous studies have suggested potential benefits of zinc in glucose metabolism.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lancaster, Pennsylvania
- Amish Research Clinic — Lancaster, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Joshua P Lewis, PhD — University of Maryland, Baltimore
- Study coordinator: Joshua P Lewis, PhD
- Email: jlewis2@som.umaryland.edu
- Phone: 410-706-5087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.