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

Trial Summary

What is the purpose of this trial?

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 gluconate 30 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.

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 data supports the effectiveness of the drug Zinc Acetate 25 MG for prediabetes?

Research shows that zinc supplementation can help improve blood sugar control and other metabolic factors in people with diabetes, suggesting it might also be beneficial for those with prediabetes. ^{1 2 3 4 5}

Is zinc supplementation safe for humans?

Zinc supplementation is generally considered safe for humans, as studies have shown it can improve glucose control without significant adverse effects. However, it's always important to follow recommended dosages and consult with a healthcare provider before starting any new supplement. ^{1 3 4 6 7}

How does zinc supplementation differ from other treatments for prediabetes?

Zinc supplementation is unique for prediabetes as it may help improve blood sugar control and prevent progression to diabetes by enhancing insulin sensitivity and beta cell function, which are crucial for managing blood sugar levels. ^{1 3 5 8 9}

Research Team

Joshua P Lewis, PhD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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 use a denture adhesive that contains zinc.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Zinc supplementation for improving glucose handling in pre-diabetes: A double blind randomized placebo controlled pilot study. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Zinc supplementation in prediabetes mellitus. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial. [2022]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effect of zinc supplementation on blood glucose level in different age groups of diabetes type 2. [2023]

9. Greece pubmed.ncbi.nlm.nih.gov

Preventive effect of zinc acexamate administration in streptozotocin-diabetic rats: Restoration of bone loss. [2013]