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Effect of Zinc on Glucose Homeostasis

Primary Purpose

Prediabetic State, Hyperglycemia

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zinc Acetate 25 MG
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prediabetic State

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amish Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc treatment

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
April 17, 2023
Last Updated
August 14, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT05835037
Brief Title
Effect of Zinc on Glucose Homeostasis
Official Title
Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Hyperglycemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zinc treatment
Arm Type
Experimental
Arm Description
Research subjects administered zinc acetate for 1 year (one 25 mg tablet per day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Research subjects administered placebo for 1 year (1 tablet per day)
Intervention Type
Drug
Intervention Name(s)
Zinc Acetate 25 MG
Other Intervention Name(s)
Galzin 25 mg
Intervention Description
Participants will take one tablet per day (25mg Zinc acetate [Galzin]) for 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will take one placebo tablet per day for 1 year
Primary Outcome Measure Information:
Title
Zinc-dependent effect on fasting glucose levels at 1 year
Description
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
Title
Zinc-dependent effect on HbA1c at 1 year
Description
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 Outcome Measure Information:
Title
Zinc-dependent effect on fasting glucose levels at 6 months
Description
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
Title
Zinc-dependent effect on HbA1c at 6 months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua P Lewis, PhD
Phone
410-706-5087
Email
jlewis2@som.umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hilary B Whitlatch, MD
Phone
443-682-6800
Email
hwhitlatch@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua P Lewis, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amish Research Clinic
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.

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Effect of Zinc on Glucose Homeostasis

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