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Trial registered on ANZCTR


Registration number
ACTRN12611001002976
Ethics application status
Not yet submitted
Date submitted
19/09/2011
Date registered
20/09/2011
Date last updated
20/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
In pre-diabetic adults aged 30-65 does zinc supplementation improve glycemic control over 6 months compared with placebo?
Scientific title
In pre-diabetic adults aged 30-65 does zinc supplementation over 6 months compared with placebo improve glycemic control?
Secondary ID [1] 263063 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 270797 0
Condition category
Condition code
Metabolic and Endocrine 270990 270990 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 milligram zinc sulphate tablet daily over a period of six months
Intervention code [1] 269414 0
Prevention
Intervention code [2] 269419 0
Treatment: Drugs
Comparator / control treatment
30 milligram placebo tablet daily over a period of six months
Control group
Placebo

Outcomes
Primary outcome [1] 279654 0
Decrease of fasting serum glucose level by 5%
Timepoint [1] 279654 0
After six months of daily treatment by 30mg zinc sulphate tablet
Secondary outcome [1] 294134 0
Increase of insulin sensitivity by 5%. We will determine the insulin sensitivity at the baseline and after the intervention using HOMA-2 calculator by measuring fasting blood glucose level and serum insulin level.
Timepoint [1] 294134 0
After six months of daily treatment by 30mg zinc sulphate tablet
Secondary outcome [2] 294135 0
Increase of pancreatic beta cell function by 5%. We will determine the pancreatic beta cell function at the baseline and after the intervention using HOMA-2 calculator by measuring fasting blood glucose level and serum insulin level.
Timepoint [2] 294135 0
After six months of daily treatment by 30mg zinc sulphate tablet
Secondary outcome [3] 294144 0
Decrease of insulin resistance by 5%. We will determine the insulin resistance at the baseline and after the intervention using HOMA-2 calculator by measuring fasting blood glucose level and serum insulin level.
Timepoint [3] 294144 0
After six months of daily treatment by 30mg zinc sulphate tablet

Eligibility
Key inclusion criteria
1. 30 to 65 yrs with BMI=23-27kg/m2 (overweight for South Asian Population) and;
2. Oral glucose tolerance test (GTT) with results 8mmol/l to 11mmol/l at the beginning.
3. Diagnosed as ‘prediabetic’ following a previous GTT within last 12 months.
4. Resident of Dhaka city corporation and likely to live in the city during the study period.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
These include: known diabetes mellitus, pregnancy, renal insufficiency, cardiovascular disease, thyroid disease, liver disease or any other chronic disease, multiple co-morbidities, physical inactivity (wheelchair bound), psychiatric disorders, gastrointestinal disorders, pharmacology agents that may interfere with the intervention (for example, diuretics, and complementary medicines), morbid obesity. These will be determined from the results of the survey, clinical assessment and pathology testing.
These criteria are based on previous studies and are used to minimise confounding and drug interactions that may interfere with the intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Having fulfilled all inclusion criteria, written consent will be obtained from each participant before recruiting into the study. Each participant will then attend the BIHS clinic to be randomized. Prior to attending the clinic, participants will be mailed a food frequency questionnaire to obtain information on usual dietary intake
Given the small sample size, block randomisation will be done to ensure equal number of participants in treatment and placebo arms of the trials. Allocation will be concealed by phoning to the central co-ordinating office. Participants will be randomly allocated to active (30mg/day zinc gluconate) or control tablets/capsules, the latter being a tablet/capsule identical in appearance to the intervention. Following randomisation participants will receive the intervention or placebo along with a BIHS pathology form to have the following measured: FBC, GTT, Serum Zinc, Serum insulin, HbA1C, Lipid Profile, Blood urea and serum creatinine, and CRP. All participants will also receive the Australian Diabetic Association guide to health eating and lifestyle.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated BLOCK randomization schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3849 0
Bangladesh
State/province [1] 3849 0
Dhaka

Funding & Sponsors
Funding source category [1] 269884 0
University
Name [1] 269884 0
The University of Newcastle
Country [1] 269884 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Centre for Clinical Epidemiology and Biostatistics (CCEB)
School of Medicine and Public Health, Faculty of Health
The University of Newcastle
David Maddision Bulding
Level 2, Corner of King and Watt Street
Newcastle, NSW 2300
Australia
Country
Australia
Secondary sponsor category [1] 268900 0
None
Name [1] 268900 0
Address [1] 268900 0
Country [1] 268900 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271852 0
Human Research Ethics Committee (HREC), The University of Newcastle
Ethics committee address [1] 271852 0
HREC
The University of Newcastle
University Drive, Callaghan Campus
Newcastle, NSW 2308, Australia.
Fax: 4921 7164
Email: [email protected]
Ethics committee country [1] 271852 0
Australia
Date submitted for ethics approval [1] 271852 0
20/07/2011
Approval date [1] 271852 0
15/08/2011
Ethics approval number [1] 271852 0
H-2011-0194

Summary
Brief summary
Zinc has been shown to improve blood glucose levels and insulin resistance in diabetic subjects in a small number of animal and human observation and interventional studies. (2-9)To extend the results of these studies, we propose to perform a pilot, double blinded randomised controlled trial in an at risk pre-diabetic adult population in Bangladesh aged 30-65 years to determine if zinc supplementation can reduce blood glucose and insulin resistance compared to placebo over a six months period.

Aims
To perform a pilot double blinded randomized controlled trial in an at-risk pre-diabetic population aged 30-65 years to determine if zinc supplementation will:
1. reduce impaired glucose tolerance levels
2. reduce insulin resistance
3. increase insulin sensitivity
4. increase pancreatic beta cell function

Hypotheses
1. In a pilot double blinded randomised controlled trial of an at-risk pre-diabetic population of those 30-65 years, zinc supplementation (30mg/day) will decrease fasting serum glucose by 5% over six months compared to a placebo treatment.

2. In a pilot double blinded randomised controlled trial of an at-risk pre-diabetic population of those 30-65 years, zinc supplementation (30mg/day) will decrease insulin resistance by 5% over six months compared to a placebo treatment.

3. In a pilot double blinded randomised controlled trial of an at-risk pre-diabetic population of those 30-65 years, zinc supplementation (30mg/day) will increase insulin sensitivity by 5% over six months compared to a placebo treatment.

4. In a pilot double blinded randomised controlled trial of an at-risk pre-diabetic population of those 30-65 years, zinc supplementation (30mg/day) will increase pancreatic beta cell function by 5% over six months compared to a placebo treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33177 0
Address 33177 0
Country 33177 0
Phone 33177 0
Fax 33177 0
Email 33177 0
Contact person for public queries
Name 16424 0
Dr Mohammad Abul Hasnat
Address 16424 0
Senior Lecturer
CCEB, School of Medicine and Public Health
Faculty of Health
Level 2, David Maddision Building
Corner of King and Watt Street
The University of Newcastle
Newcastle, NSW 2300
Australia
Country 16424 0
Australia
Phone 16424 0
+61 2 49138200, +61 (0) 412141971
Fax 16424 0
+61 2 49138148
Email 16424 0
[email protected]
Contact person for scientific queries
Name 7352 0
Dr Mohammad Abul Hasnat
Address 7352 0
Senior Lecturer
CCEB, School of Medicine and Public Health
Faculty of Health
Level 2, David Maddision Building
Corner of King and Watt Street
The University of Newcastle
Newcastle, NSW 2300
Australia
Country 7352 0
Australia
Phone 7352 0
+61 2 49138200, +61 (0) 412141971
Fax 7352 0
+61 2 49138148
Email 7352 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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