Zinc in Preventing the Progression of Pre-Diabetes

Phase 3

• Conditions: Pre-Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618001120268
• Lead Sponsor: Professsor John Attia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-06
• Study Completion: 2020-06-11
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Prediabetes, defined by a HbA1c of 5.7-6.4

Exclusion Criteria

One or more of the following:
Taking any other vitamin or mineral supplementation containing zinc;
Currently using weight loss medication;
Pregnancy or lactation for women of child-bearing age;
Impaired hepatic or renal function;
Taking pharmacology agents that may interfere with the intervention (for example, metformin, and complementary medicines).
Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study (current cancer under treatment, terminal cancer, terminal illness).
Persons who are unable to read and understand the information statement and consent form are ineligible. Informed consent must be obtained to be eligible for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c. [1 year post intervention commencement.];Change in insulin sensitivity (as per HOMA model)[1 year post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method
progression to diabetes (as per HbA1c)[1 year post intervention commencement.];change in CVD risk factors (as measured by Cholesterol)[1 year post intervention commencement.];change in CVD risk factors (as measured by BMI and waist circumference)[1 year post intervention commencement.];acceptability of supplements (as measured by pill counts) [1 year post intervention commencement.]