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New treatment option for Prediabetic State
Official title Effect of Zinc on Glucose Homeostasis
ClinicalTrials.gov ID: NCT05835037
What this study is testing
What is Zinc Gluconate 30 MG?
Zinc Gluconate 30 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prediabetic state.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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 likely can't join 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)
See the full eligibility 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)
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lancaster, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lancaster, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.