Not Yet RecruitingPhase 3ACTRN12611001002976

In pre-diabetic adults aged 30-65 does zinc supplementation improve glycemic control over 6 months compared with placebo?

In pre-diabetic adults aged 30-65 does zinc supplementation over 6 months compared with placebo improve glycemic control?

Sponsor

The University of Newcastle

Enrollment

40 participants

Start Date

Oct 1, 2011

Study Type

Interventional

Conditions

Prediabetes

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.

Eligibility

Sex: Both males and femalesMin Age: 30 YearssMax Age: 65 Yearss

Inclusion Criteria4

30 to 65 yrs with BMI=23-27kg/m2 (overweight for South Asian Population) and;
Oral glucose tolerance test (GTT) with results 8mmol/l to 11mmol/l at the beginning.
Diagnosed as ‘prediabetic’ following a previous GTT within last 12 months.
Resident of Dhaka city corporation and likely to live in the city during the study period.

Exclusion Criteria2

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.

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