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


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
15 Apr 2019
Historique:
received: 12 11 2018
accepted: 21 03 2019
entrez: 18 4 2019
pubmed: 18 4 2019
medline: 30 8 2019
Statut: epublish

Résumé

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. 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. 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. Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268 . Registered on 6 July 2018.

Sections du résumé

BACKGROUND 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 METHODS
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 CONCLUSIONS
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 BACKGROUND
Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268 . Registered on 6 July 2018.

Identifiants

pubmed: 30992081
doi: 10.1186/s13063-019-3317-4
pii: 10.1186/s13063-019-3317-4
pmc: PMC6466783
doi:

Substances chimiques

Glycated Hemoglobin A 0
hemoglobin A1c protein, human 0
Zinc J41CSQ7QDS

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

219

Subventions

Organisme : NSW Ministry of Health
ID : H18/31636

Références

Obes Rev. 2005 Aug;6(3):187-9
pubmed: 16045631
J Cell Sci. 2006 Oct 15;119(Pt 20):4199-206
pubmed: 16984975
Diabetes Care. 2007 Mar;30(3):753-9
pubmed: 17327355
Med J Aust. 2007 May 7;186(9):461-5
pubmed: 17484708
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Diabetes Care. 2009 Apr;32(4):629-34
pubmed: 19171718
J Nutr Biochem. 2009 Jun;20(6):399-417
pubmed: 19442898
J Am Chem Soc. 2010 Jul 7;132(26):8973-83
pubmed: 20536124
Aust N Z J Public Health. 2010 Jun;34(3):311-4
pubmed: 20618275
Diabetes Care. 2011 Feb;34(2):518-23
pubmed: 21270207
Health Educ Res. 2011 Dec;26(6):1097-106
pubmed: 21987479
Diabetol Metab Syndr. 2012 Apr 19;4(1):13
pubmed: 22515411
J Trace Elem Med Biol. 2013 Apr;27(2):137-42
pubmed: 23137858
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
BMC Endocr Disord. 2013 Oct 04;13:40
pubmed: 24093747
Ann Intern Med. 2013 Oct 15;159(8):543-51
pubmed: 24126648
Biomed Res Int. 2015;2015:217047
pubmed: 26539470
Diabetes Res Clin Pract. 2016 May;115:39-46
pubmed: 27242121
Diabetes Res Clin Pract. 2017 Jun;128:40-50
pubmed: 28437734
J Diabetes. 2018 May;10(5):386-397
pubmed: 29072815
J Biol Chem. 1995 Sep 1;270(35):20417-23
pubmed: 7657617
J Am Coll Nutr. 1998 Apr;17(2):109-15
pubmed: 9550453

Auteurs

Roseanne Peel (R)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.

Alexis Hure (A)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.

John Wiggers (J)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Health Research and Translation and Population Health, Hunter New England Local Health District, New Lambton, NSW, Australia.

Mark McEvoy (M)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.

Elizabeth Holliday (E)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.

Andrew Searles (A)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Hunter Medical Research Institute, Newcastle, NSW, Australia.

Penny Reeves (P)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.
Hunter Medical Research Institute, Newcastle, NSW, Australia.

Priyanga Ranasinghe (P)

Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.

Ranil Jayawardena (R)

Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Department of Physiology Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.

Samir Samman (S)

School of Life and Environmental Sciences, University of Sydney, Sydney, NSW, Australia.

Shamasunder Acharya (S)

Division of Medicine, Hunter New England Local Health District, New Lambton, NSW, Australia.
Diabetes Alliance, Hunter New England Local Health District, New Lambton, NSW, Australia.

Judy Luu (J)

Division of Medicine, Hunter New England Local Health District, New Lambton, NSW, Australia.
Diabetes Alliance, Hunter New England Local Health District, New Lambton, NSW, Australia.

Chris Rissel (C)

The NSW Office of Preventive Health, South Western Sydney Local Health District, Liverpool Hospital, Liverpool, NSW, Australia.

John Attia (J)

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia. john.attia@newcastle.edu.au.
Division of Medicine, Hunter New England Local Health District, New Lambton, NSW, Australia. john.attia@newcastle.edu.au.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH