None listed
Conditions
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.
Interventions
30 milligram zinc sulphate tablet daily over a period of six months
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed