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NCT05835037 · ClinicalTrials.gov registry record · Phase 4
Effect of Zinc on Glucose Homeostasis
A Phase 4 study of Hyperglycemia and Prediabetic State, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05835037 is a Phase 4 study of Hyperglycemia and Prediabetic State that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 200 participants, below the 874-participant average among 38 other Hyperglycemia trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05835037, a Phase 4 study of Hyperglycemia and Prediabetic State, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Zinc Gluconate 30 MG
Study Locations (1)
Pennsylvania
- Amish Research Clinic - Lancaster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-02-16 |
| Est. Completion | 2028-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835037
The ClinicalTrials.gov registry entry for NCT05835037 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 874-participant average among 38 other Hyperglycemia trials with a reported enrollment target (77% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hyperglycemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05835037 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05835037 about?
NCT05835037 is a clinical study titled "Effect of Zinc on Glucose Homeostasis". 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 g...
What is the current status of trial NCT05835037?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2024-02-16. Estimated completion is 2028-07.
What conditions does trial NCT05835037 study?
This clinical trial studies the following conditions: Hyperglycemia, Prediabetic State.
What interventions are being tested in trial NCT05835037?
The interventions under investigation include: Placebo (DRUG), Zinc Gluconate 30 MG (DRUG).
Who is sponsoring clinical trial NCT05835037?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835037 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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