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Zinc for Prediabetes
Phase 4
Recruiting
Led By Joshua P Lewis, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Amish men or women who are 18 to 80 years old
Be older than 18 years old
Must not have
Use of denture adhesive containing zinc
Has hemochromatosis, cancer, liver disease, kidney disease, cardiovascular disease, or other coexisting malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to see if taking zinc supplements can help lower blood glucose and HbA1c levels in people with prediabetes. 200 people will be studied and monitored for 12 months.
Who is the study for?
This trial is for Amish men and women aged 18-80 with prediabetes. Participants should not be on certain medications like corticosteroids or antidepressants, have zinc hypersensitivity, severe gastrointestinal issues, or major organ dysfunction. Pregnant individuals and those with conditions such as hemochromatosis or severe hypertension are excluded.
What is being tested?
The study tests if taking Zinc Acetate (25 MG daily) for a year improves blood sugar control in prediabetics compared to a placebo. It's double-blind, meaning neither the researchers nor participants know who gets zinc or placebo. Measurements of glucose levels will occur at the start, after 6 months, and at one year.
What are the potential side effects?
Potential side effects from Zinc Acetate may include digestive discomfort and metallic taste. Long-term use can lead to copper deficiency which might cause anemia or nerve damage; however specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an Amish person aged between 18 and 80.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use a denture adhesive that contains zinc.
Select...
I have a condition like hemochromatosis, cancer, liver, kidney, heart disease, or another cancer.
Select...
My kidney, liver, blood, or thyroid test results are outside the normal range.
Select...
I have had severe stomach issues or major stomach surgery.
Select...
My blood pressure is higher than 160/95 mm Hg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Zinc-dependent effect on HbA1c at 1 year
Zinc-dependent effect on fasting glucose levels at 1 year
Secondary study objectives
Zinc-dependent effect on HbA1c at 6 months
Zinc-dependent effect on fasting glucose levels at 6 months
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zinc treatmentExperimental Treatment1 Intervention
Research subjects administered zinc gluconate for 1 year (one 30 mg tablet per day)
Group II: PlaceboPlacebo Group1 Intervention
Research subjects administered placebo for 1 year (1 tablet per day)
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,292 Total Patients Enrolled
4 Trials studying Diabetes
23,990 Patients Enrolled for Diabetes
Joshua P Lewis, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
2 Previous Clinical Trials
117 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor agrees that my current medications won't interfere with the study.I use a denture adhesive that contains zinc.I have a condition like hemochromatosis, cancer, liver, kidney, heart disease, or another cancer.My kidney, liver, blood, or thyroid test results are outside the normal range.Your hemoglobin levels are lower than 12.5 g/dl if you are male, or lower than 11 g/dl if you are female.I cannot or will not stop taking my current medications or zinc supplements 2 weeks before starting the study.I am an Amish person aged between 18 and 80.Your blood sugar levels are higher than normal, but not high enough to be considered diabetes.I have had severe stomach issues or major stomach surgery.You are allergic to zinc.My blood pressure is higher than 160/95 mm Hg.
Research Study Groups:
This trial has the following groups:- Group 1: Zinc treatment
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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