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Effect of Zinc on Glucose Homeostasis

ConditionsPrediabetic StateHyperglycemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Maryland, Baltimore

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zinc Gluconate 30 MG

    Drug

    Participants will take one tablet per day (30 mg Zinc gluconate) for 1 year

  • Placebo

    Drug

    Participants will take one placebo tablet per day for 1 year

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Zinc treatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Zinc-dependent effect on fasting glucose levels at 1 year

One of the investigator's primary endpoints will be to determine the difference in fasting glucose levels between zinc-treated and placebo-treated individuals after 1 year of receiving study drug

Time frame
1 year
2

Zinc-dependent effect on HbA1c at 1 year

One of the investigator's primary endpoints will be to determine the difference in HbA1c levels between zinc-treated and placebo-treated individuals after 1 year of receiving study drug

Time frame
1 year

Secondary outcomes

1

Zinc-dependent effect on fasting glucose levels at 6 months

One of the investigator's secondary endpoints will be to determine the difference in fasting glucose levels between zinc-treated and placebo-treated individuals after 6 months of receiving study drug

Time frame
6 months
2

Zinc-dependent effect on HbA1c at 6 months

One of the investigator's secondary endpoints will be to determine the difference Hba1c between zinc-treated and placebo-treated individuals after 6 months of receiving study drug

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov
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