Zinc in Preventing the Progression of Pre-Diabetes

Conditions

None listed

Brief summary

The study is a randomised, placebo-controlled, double-blind trial. Participants aged 40-70 with pre-diabetes (as per HbA1c) will be invited to participate through GP Practices involved in the diabetes alliance. Participants will be randomly allocated on a ratio1:1, to receive zinc or control treatment options, and followed up at one month, three months, six months and twelve months. Both treatment arms will have Get Healthy Information and Coaching Service, type 2 diabetes Prevention Program involved in their care for the first six months of the trial.

Attia J, Weaver N, Peel R, Fleming K, Holliday E, Rissel C, Bauman A, Wiggers J, Acharya S, Luu J, Reeves P, McEvoy M, Hure A.

2024-09-02

10.1186/s12889-024-19849-0

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial.

Attia JR, Holliday E, Weaver N, Peel R, Fleming KC, Hure A, Wiggers J, McEvoy M, Searles A, Reeves P, Ranasinghe P, Jayawardena R, Samman S, Luu J, Rissel C, Acharya S.

2022-04-2213 citations

10.1007/s00592-022-01888-x

Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia.

Peel R, Hure A, Wiggers J, McEvoy M, Holliday E, Searles A, Reeves P, Ranasinghe P, Jayawardena R, Samman S, Acharya S, Luu J, Rissel C, Attia J.

2019-04-156 citations

10.1186/s13063-019-3317-4

Interventions

The Intervention is a zinc gluconate 30mg capsule supplement to be taken once daily for one year. Outcome data for this trial will be ascertained through changes in HbA1c levels at baseline, one month, six months and twelve months, in the two arms of the study. Participants will be provided a reply paid padded envelope to return the unused capsules, which will be counted for compliance and acceptability of the supplement. All participants will receive standard care with the intervention. Standar

The Intervention is a zinc gluconate 30mg capsule supplement to be taken once daily for one year. Outcome data for this trial will be ascertained through changes in HbA1c levels at baseline, one month, six months and twelve months, in the two arms of the study. Participants will be provided a reply paid padded envelope to return the unused capsules, which will be counted for compliance and acceptability of the supplement. All participants will receive standard care with the intervention. Standard care is a NSW health initiative called the "Get Healthy Information and Coaching Service", to improve the lifestyle (smoking, exercise, alcohol use, weight losss) of persons with pre-diabetes. The "Get Healthy Information and Coaching Service", will provide 13 health motivational phone calls to all participants over a 6 month period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Healthy volunteers

No

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.

Outcome results