Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 4 study of Hyperglycemia and Prediabetic State, sponsored by University of Maryland, Baltimore.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
One of the investigator's primary endpoints will be to determine the difference in fasting glucose levels between zinc-treated and placebo-treated individuals after 1 year of receiving study drug
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 |
What NCT05835037 shows while recruiting
NCT05835037 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 874-participant average among 38 other Hyperglycemia trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hyperglycemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05835037's enrollment target sits among peer trials
200 10th of 38 higher than 27 of 38 other Hyperglycemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperglycemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
COMPLETED · Phase 4
-
Diabetes in the Elderly: Prospective Study
COMPLETED · Phase 4
-
Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism
COMPLETED · Phase 4
-
Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy
COMPLETED · Phase 4
-
Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
COMPLETED · Phase 4
-
Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI