Zinc Supplementation Improves Cardiovascular Morbidity in Patients With Diabetes Mellitus

NCT05000762 | Withdrawn DMC

• 1 other identifier: IRB-20-10-2833
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Oral zinc supplementation in patients with diabetes mellitus can improve glycemic control. However, there is reluctance to recommend zinc supplements to these patients because there is no evidence that the zinc-dependent improvement in glycemic control offers protections from the cardiovascular morbidities associated with diabetes mellitus, especially myocardial infarction and thrombotic stroke. The investigators are conducting a randomized, double blind, cross over study to test the hypothesis that oral zinc supplementation will block the enhanced cardiovascular, cerebrovascular, and platelet reactivity that lead to myocardial infarction and stroke in research participants with diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

Zinc dietary supplement; diabetes mellitus; cardiovascular reactivity

Outcome Measures

Primary Outcomes (4)

• Pulse wave velocity

  Measure changes non-invasively wtihcarotid-femoral pulse wave velocity

  4 months

• Cerebrovascular reactivity

  Measure vasodilation in response to increasing pCO2

  4 months

• Blood pressure response to exercise

  Assess blood pressure response to hand grip exercise

  4 months

• Platelet aggregation

  Measure catecholamine-induced platelet aggregation ex vivo

  4 months

Study Arms (1)

Patients with diabetes mellitus

Patients with type 2 diabetes mellitus

Dietary Supplement: Zinc

Interventions

Zinc DIETARY_SUPPLEMENT

Zinc gluconate 30 mg/day orally

Patients with diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women between the ages of 18 - 75 years who have stable type 2 diabetes or pre-diabetes reflected by a glycosylated heoglobin A1C between 6% - 9%. On no prescription medications other than for diabetes mellitus or nutritional supplements containing zinc

You may qualify if:

• Only patients with stable type 2 diabetes mellitus or pre-diabetes (HgbA1c between 6% - 9%) and who are otherwise healthy

You may not qualify if:

• Pregnant women
• Anyone unable to understand or give informed consent

Sponsors & Collaborators

• Wayne State University: lead
• QPathology: collaborator

Study Sites (1)

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Jayawardena R, Ranasinghe P, Galappatthy P, Malkanthi R, Constantine G, Katulanda P. Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis. Diabetol Metab Syndr. 2012 Apr 19;4(1):13. doi: 10.1186/1758-5996-4-13.

  PMID: 22515411 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus

Interventions

Zinc

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Warren Lockette, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Endocrinology

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)