Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
200 (estimated)
Sponsor
University of Maryland, Baltimore · Other
Who this trial is looking for
This trial is looking for Amish men and women ages 18 to 80 with prediabetes. Participants will take zinc or a placebo for one year to see how it affects their blood sugar levels.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old
I have prediabetes
You may not be able to join if
I am pregnant
I am currently breastfeeding
I have severe gastrointestinal disorders
I have hemochromatosis
I have cancer
I have liver disease
I have kidney disease
I have severe hypertension
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Spec…
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.
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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 hemochromat…
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.
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