Effect of Zinc on Glucose Homeostasis
Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes
1 other identifier
interventional
200
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
May 5, 2026
April 1, 2026
4.4 years
April 17, 2023
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
1 year
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
1 year
Secondary Outcomes (2)
Zinc-dependent effect on fasting glucose levels at 6 months
6 months
Zinc-dependent effect on HbA1c at 6 months
6 months
Study Arms (2)
Zinc treatment
EXPERIMENTALResearch subjects administered zinc gluconate for 1 year (one 30 mg tablet per day)
Placebo
PLACEBO COMPARATORResearch subjects administered placebo for 1 year (1 tablet per day)
Interventions
Participants will take one tablet per day (30 mg Zinc gluconate) for 1 year
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amish Research Clinic
Lancaster, Pennsylvania, 17602, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua P Lewis, PhD
University of Maryland, Baltimore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
April 17, 2023
First Posted
April 28, 2023
Study Start
February 16, 2024
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- In is anticipated that data would become available following the completion of the study and within 6 months of the publication of the primary analyses.
- Access Criteria
- To be determined
It is possible that deidentified data will be deposited into large public databases as per NIH data sharing policies (e.g. database of Genotypes and Phenotype \[dbGAP\], Pharmacogenomics Knowledgebase \[PharmGKB\], etc.). Data to be shared would include, but not limited to, anthropometric data, study outcome data, and relevant covariate data used in statistical models. It is anticipated that data would be available after the completion of the trial. The data will be obtained from the participants and the study-related research procedures.