Zinc for Prediabetes

Overseen By Hilary B Whitlatch, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Must not be taking: Corticosteroids, Antipsychotics, Protease inhibitors, others

Disqualifiers: Pregnant, Cancer, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether zinc can help control blood sugar levels in people with prediabetes. Participants will receive either a zinc supplement (Zinc Acetate 25 MG) or a placebo (a pill with no active ingredient) for a year to determine if zinc reduces blood sugar and improves other diabetes-related markers. The trial seeks Amish men and women with prediabetes, specifically those with higher-than-normal blood sugar levels that do not qualify as diabetes. As a Phase 4 trial, this research explores how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they affect the study's outcomes, such as corticosteroids, anti-psychotic agents, and some antidepressants. If you are taking other medications or zinc supplements, you must be willing to stop them at least 2 weeks before starting the trial, unless the study physician advises otherwise.

What is the safety track record for these treatments?

Research shows that zinc is generally safe for people. Studies have found that zinc can help control blood sugar levels in individuals who are overweight or have diabetes. It can lower fasting blood sugar levels and improve insulin utilization, which is promising for those with prediabetes.

Most people tolerate zinc well, with only a few side effects reported. However, excessive zinc intake can sometimes cause nausea or an upset stomach, so it's important to adhere to the recommended dose. The FDA has already approved zinc for other uses, indicating its safety when used properly.

Overall, zinc appears promising for managing blood sugar levels and is considered safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about zinc acetate for prediabetes because it offers a potential new way to manage blood sugar levels. Unlike standard treatments like lifestyle changes and medications such as metformin, zinc acetate may improve insulin sensitivity by providing the body with an essential mineral that plays a role in glucose metabolism. This unique approach could offer an alternative or complementary option for those with prediabetes, possibly helping to delay or prevent the progression to type 2 diabetes.

What evidence suggests that zinc supplementation might be an effective treatment for prediabetes?

Research has shown that zinc can help manage prediabetes. In one study, zinc reduced the chance of developing diabetes from 25% to 11% over a year. Another study found that zinc significantly lowered fasting blood sugar levels and reduced insulin resistance. A review of several studies found that zinc helps control blood sugar in people who are overweight or obese. In this trial, participants in the zinc treatment arm will receive zinc gluconate, while those in the placebo arm will receive a dummy treatment. These findings suggest that zinc can benefit people with prediabetes by improving key measures of blood sugar control. ^{1 2 4 5 6}

Who Is on the Research Team?

Joshua P Lewis, PhD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

My doctor agrees that my current medications won't interfere with the study.

I have a condition like hemochromatosis, cancer, liver, kidney, heart disease, or another cancer.

I use a denture adhesive that contains zinc.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 home visit

Treatment

Participants receive zinc gluconate or placebo for 12 months to assess effects on glucose homeostasis

12 months

3 clinic visits (baseline, 6 months, 12 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Zinc Acetate 25 MG

Trial Overview 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.

How Is the Trial Designed?

Group I: Zinc treatment Experimental Treatment 1 Intervention

Research subjects administered zinc gluconate for 1 year (one 30 mg tablet per day)

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a double-blind randomized placebo-controlled trial involving 55 participants with prediabetes, zinc supplementation (30mg daily for 6 months) significantly improved fasting blood glucose levels compared to placebo, indicating its potential to help prevent diabetes progression.

The study also showed significant enhancements in beta cell function, insulin sensitivity, and reductions in insulin resistance, suggesting that zinc may play a beneficial role in glucose metabolism for those at risk of developing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc supplementation for improving glucose handling in pre-diabetes: A double blind randomized placebo controlled pilot study. Islam, MR., Attia, J., Ali, L., et al.[2018]

Zinc supplementation significantly reduced fasting blood glucose (FBG) levels in individuals with prediabetes, with reductions of approximately 10.86 mg/dL when taken alone and 11.77 mg/dL when combined with other nutrients, based on a meta-analysis of 265 participants across three studies.

The supplementation also led to improvements in other glycemic parameters, including a reduction in 2-hour oral glucose tolerance test (OGTT) blood glucose by 21.08 mg/dL and a decrease in HbA1c by 0.5%, suggesting that zinc may help manage prediabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc supplementation in prediabetes mellitus. Jayawardena, R., Ranasinghe, P., Kodithuwakku, W., et al.[2022]

Zinc supplementation significantly reduces fasting blood glucose levels by an average of 18.13 mg/dl and post-prandial blood sugar by 34.87 mg/dl in patients with type-2 diabetes, based on a meta-analysis of 25 studies involving both type-1 and type-2 diabetes.

The analysis also found that Zinc supplementation leads to a reduction in HbA1c by 0.54% and improves lipid profiles, with total cholesterol decreasing by 32.37 mg/dl and LDL cholesterol by 11.19 mg/dl, indicating its potential benefits for glycaemic control and cardiovascular health in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis. Jayawardena, R., Ranasinghe, P., Galappatthy, P., et al.[2022]

This study will evaluate the effects of zinc supplementation on glycemic control in 200 adults with pre-diabetes over 12 months, aiming to determine its potential in preventing diabetes.

The randomized, double-blind, placebo-controlled design will ensure reliable results, measuring key metabolic parameters like fasting plasma glucose and HbA1c to assess the efficacy of zinc in managing pre-diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial. Ranasinghe, P., Jayawardena, R., Pigera, AS., et al.[2022]

In a randomized, double-blind, placebo-controlled trial involving 98 pre-diabetic adults, zinc supplementation (30 mg daily) did not significantly improve glycaemic control, as measured by HbA1c and fasting blood glucose levels, after 6 months.

Zinc supplementation was well tolerated with high compliance (88%), but the study suggests that it may not be beneficial for individuals in Western diets, although it could still be useful in populations with zinc deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial. Attia, JR., Holliday, E., Weaver, N., et al.[2022]

Zinc supplementation (20 mg/day) significantly lowered fasting blood glucose levels in type-2 diabetic patients after 60 days, particularly in older patients aged 51-70 years, indicating its potential efficacy in managing diabetes.

The study suggests that older adults may have a better response to zinc supplementation compared to younger adults (30-50 years), possibly due to higher zinc demands as people age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of zinc supplementation on blood glucose level in different age groups of diabetes type 2. Aslam, M., Bashir, S., Zeb, A.[2023]

In a study involving STZ-diabetic rats, zinc acexamate significantly prevented bone loss by maintaining alkaline phosphatase activity, calcium, and DNA levels, which were otherwise decreased due to diabetes.

Zinc sulfate did not show the same protective effects on bone components, highlighting that zinc acexamate may be a more effective option for preventing bone loss in diabetic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive effect of zinc acexamate administration in streptozotocin-diabetic rats: Restoration of bone loss. Yamaguchi, M., Uchiyama, S.[2013]

In a clinical trial with 84 participants over 90 days, supplementation with zinc and curcumin significantly improved key glycemic parameters, including fasting plasma glucose and HbA1C, compared to a placebo group.

Participants taking zinc alone or in combination with curcumin also experienced a significant reduction in body mass index (BMI), indicating potential benefits for weight management in prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of curcumin and zinc co-supplementation on glycemic parameters in overweight or obese prediabetic subjects: A phase 2 randomized, placebo-controlled trial with a multi-arm, parallel-group design. Karandish, M., Mozaffari-Khosravi, H., Mohammadi, SM., et al.[2021]

In a 12-month study involving 200 participants, zinc supplementation (20 mg daily) significantly reduced the progression to type 2 diabetes, with only 11% of the zinc group developing diabetes compared to 25% in the control group.

Zinc treatment also led to lower fasting plasma glucose, improved insulin resistance, and better β-cell function, indicating its potential as an effective intervention for managing prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial. Ranasinghe, P., Wathurapatha, WS., Galappatthy, P., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6635284/

The effect of zinc supplementation in pre-diabetes Results: This study will provide high-quality synthesis of effectiveness and safety of zinc supplementation for pre-diabetes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1871403X23000637

Effect of zinc supplementation on blood sugar control in the ... Our meta-analysis indicated that zinc supplementation benefits blood sugar control in overweight and obese populations, with an especially significant ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3317-4

Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD ... A randomised controlled trial of zinc supplementation among people with PreDM reduced progression to diabetes from 25% to 11% over 1 year [1].

4. journals.lww.com journals.lww.com/md-journal/fulltext/2019/07050/the_effect_of_zinc_supplementation_in.61.aspx

The effect of zinc supplementation in pre-diabetes Human studies have shown that zinc supplementation is beneficial for pre-diabetes. However, owing to the low quality, small sample size, and methodological ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1753-0407.12621

Zinc supplementation in prediabetes: A randomized double ... The results show that zinc supplementation significantly reduces FPG, 2-h OGTT plasma glucose, insulin resistance (HOMA-IR), and disease ...

6. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/counter/pdf/10.1186/s13098-024-01366-0.pdf?utm_source=consensus

Effect of zinc supplementation on glycemic biomarkers The supplementation of zinc resulted in a significant decrease in FBS levels, according to the WMD analysis (WMD: − 13.58, 95% CI − 17.38, − 9.77; p < 0.001, I ...