Effect of Zinc on Glucose Homeostasis

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Apr 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether taking zinc supplements can help lower blood sugar levels in people who are prediabetic. Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes. The study will compare two groups: one group will receive a daily zinc supplement for a year, while the other group will receive a placebo, which looks like zinc but doesn't contain any active ingredients. Researchers will measure important blood sugar markers, such as HbA1c (a test that shows average blood sugar levels over the past few months), at the start of the study, after six months, and again after a year.

To participate, individuals must be aged 18 to 80 years and diagnosed with prediabetes. The trial is looking for men and women from the Amish community who meet these criteria. However, certain people, such as those who are pregnant, have specific health conditions, or are taking certain medications, may not be eligible. Participants will need to visit the study site for testing at different points during the year, and the trial aims to include about 200 participants in total. This study is currently recruiting participants, and it hopes to improve our understanding of how zinc can affect blood sugar control in people at risk for diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Amish men or women who are 18 to 80 years old
• • Prediabetes (HgbA1c = 5.7-6.4% or fasting glucose levels 100-125 mg/dL)
• Exclusion Criteria:
• • Pregnant
• • Currently breastfeeding
• • History of severe gastrointestinal disorders or upper gastrointestinal surgery
• • Has hemochromatosis, cancer, liver disease, kidney disease, cardiovascular disease, or other coexisting malignancy
• • Hemoglobin \< 12.5 g/dl (male) or \< 11 g/dl (female)
• • Severe hypertension (blood pressure \> 160/95 mm Hg)
• • Has a creatinine greater than 2.0 mg/dl, aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 2 times the upper limit of normal, hematocrit (Hct) less than 32%, or thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 milli-international units (mIU) per liter.
• • At the discretion of the study physician or PI, taking medications that affect the outcomes of the study including, but not limited to, corticosteroids, anti-psychotic agents, protease inhibitors, oral contraceptives, estrogens, niacin, and some classes of antidepressants, statins, and antihypertensive medications
• • Zinc hypersensitivity
• • Use of denture adhesive containing zinc
• • Taking other medications or zinc-containing supplements and is unwilling or cannot safely, in the opinion of the study physician, discontinue their use at least 2 weeks prior to protocol initiation
• • Any other condition that would, in the opinion of the investigator, place them at an unacceptable risk or render them unable to meet the requirements of the protocol.