Zinc supplementation's effect on blood sugar levels in prediabetics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amish Research Clinic
  Lancaster, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Toni I Pollin, PhD — University of Maryland, Baltimore
• Study coordinator: Toni I Pollin, PhD
• Email: tpollin@som.umaryland.edu
• Phone: 410-706-1630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.