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Effect of Zinc on Glucose Homeostasis

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05835037
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 acetate 25 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Zinc Acetate 25 MG
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two hundred prediabetic individuals will be enrolled. The investigators will prospectively evaluate the impact of zinc supplementation on fasting glucose levels and HbA1c, through the completion of randomized, placebo-controlled study of zinc acetate (one 25 mg tablet per day for 1 year) and placebo (1 tablet per day for 1 year). Participants will be randomized 1:1 to either zinc or placebo.Two hundred prediabetic individuals will be enrolled. The investigators will prospectively evaluate the impact of zinc supplementation on fasting glucose levels and HbA1c, through the completion of randomized, placebo-controlled study of zinc acetate (one 25 mg tablet per day for 1 year) and placebo (1 tablet per day for 1 year). Participants will be randomized 1:1 to either zinc or placebo.
Masking:
Double (Participant, Care Provider)
Masking Description:
Enrolled subjects will be randomized (1:1) to either the zinc or placebo intervention. Clinical staff and participants will be blinded to treatment assignment. Sealed, opaque assignment envelopes will be shuffled prior to study initiation and opened sequentially by a designated member of the research team who will then deliver the correct study drug to the clinical staff.
Primary Purpose:
Basic Science
Official Title:
Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2028
Anticipated Study Completion Date :
Jul 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zinc treatment

Research subjects administered zinc acetate for 1 year (one 25 mg tablet per day)

Drug: Zinc Acetate 25 MG
Participants will take one tablet per day (25mg Zinc acetate [Galzin]) for 1 year
Other Names:
  • Galzin 25 mg

    		•
    Placebo Comparator: Placebo

    Research subjects administered placebo for 1 year (1 tablet per day)

    Drug: Placebo
    Participants will take one placebo tablet per day for 1 year

    Outcome Measures

    Primary Outcome Measures

    1. Zinc-dependent effect on fasting glucose levels at 1 year [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

    2. Zinc-dependent effect on HbA1c at 1 year [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

    Secondary Outcome Measures

    1. Zinc-dependent effect on fasting glucose levels at 6 months [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

    2. Zinc-dependent effect on HbA1c at 6 months [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amish Research Clinic Lancaster Pennsylvania United States 17602

    Sponsors and Collaborators

    • University of Maryland, Baltimore

    Investigators

    • Principal Investigator: Joshua P Lewis, PhD, University of Maryland, Baltimore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joshua Lewis, Associate Professor of Medicine, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT05835037
    Other Study ID Numbers:
    • HP-00105493
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Hyperglycemia
    Prediabetic State

    Study Results

    No Results Posted as of May 1, 2023