Prediabetic State study: Zinc Gluconate
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, taken by mouth once daily, 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 study wants to see whether taking zinc for 12 months can reduce HbA1c and fasting glucose compared to a placebo.
- Who it's for
- It is looking for adults who have prediabetes, meaning their blood sugar is higher than normal but not yet diabetic.
- What's involved
- Participants will take either a zinc gluconate tablet (30 mg daily) or a placebo. They will have blood tests at the start, after 6 months, and after 12 months to measure HbA1c and fasting glucose.
- Time commitment
- The study lasts 12 months, with blood tests and visits at baseline, 6 months, and 12 months.
- 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 is enrolling
- Lancaster, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Lancaster, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.