Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia.
BACKGROUND
Diabetes is increasing in incidence, morbidity and treatment costs globally, hence prevention strategies need to be explored. Animal studies and some human data have shown that zinc can improve glycaemic control, but the impact of this effect in a pre-diabetic population remains uncertain. This study is designed to investigate whether zinc gluconate and lifestyle coaching can improve glucose handling and ultimately reduce diabetes incidence in an at-risk pre-diabetic population in Australia.


METHODS/DESIGN
The study will be a randomised, placebo-controlled, double-blind clinical trial. The study will be conducted at the Hunter New England Local Health District New South Wales (NSW), Australia. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4) male and female participants (n = 410) aged 40-70 years will be recruited through the Diabetes Alliance Network, a collaboration of diabetes specialists and general practitioner practices. All participants will be given routine care to encourage healthy lifestyle changes using a telephone coaching service (Get Healthy Information and Coaching Service, NSW Health) and then randomised to receive a supplement, either zinc gluconate (equivalent to 30 mg of elemental zinc) or placebo of identical appearance for 12 months. The identity of the supplements will be blinded to both research personnel and the participants. Participants will be asked to complete medical, lifestyle and dietary surveys and will have baseline and final visits at their general practitioner practice. Primary outcomes will be HbA1c and insulin sensitivity collected at baseline and at 1, 6 and 12 months; secondary outcomes will include fasting blood glucose, fasting cholesterol, blood pressure and body mass index. The primary efficacy endpoint will be judged at 6 months.


DISCUSSION
This study will generate new evidence about the potential for health coaching, with or without zinc supplementation, to improve glucose handling and ultimately to reduce progression from pre-diabetes to diabetes.


TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268 . Registered on 6 July 2018.
['Peel|Roseanne|R|http://orcid.org/0000-0001-9912-3198', 'Hure|Alexis|A|', 'Wiggers|John|J|', 'McEvoy|Mark|M|', 'Holliday|Elizabeth|E|', 'Searles|Andrew|A|', 'Reeves|Penny|P|', 'Ranasinghe|Priyanga|P|', 'Jayawardena|Ranil|R|', 'Samman|Samir|S|', 'Acharya|Shamasunder|S|', 'Luu|Judy|J|', 'Rissel|Chris|C|', 'Attia|John|J|']
D000328:Adult D000368:Aged D003924:Diabetes Mellitus, Type 2 D019587:Dietary Supplements D018450:Disease Progression D004311:Double-Blind Method D005260:Female D006442:Glycated Hemoglobin A D006801:Humans D008297:Male D008875:Middle Aged D017063:Outcome Assessment, Health Care D011236:Prediabetic State D016032:Randomized Controlled Trials as Topic D015032:Zinc
Pre-diabetes Australia Healthy lifestyle Zinc supplementation Adults