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

Phase 3

• Conditions: Prediabetes; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12611001002976
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease of fasting serum glucose level by 5%[After six months of daily treatment by 30mg zinc sulphate tablet]

Secondary Outcome Measures

Name	Time	Method
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.[After six months of daily treatment by 30mg zinc sulphate tablet];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.[After six months of daily treatment by 30mg zinc sulphate tablet];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.[After six months of daily treatment by 30mg zinc sulphate tablet]