Status:
COMPLETED
The Effect of a Nutritional Supplement in Individuals With Type 2 Diabetes Mellitus: a Pilot Study
Lead Sponsor:
University of Sydney
Conditions:
Diabetes Mellitus, Type 2
Insulin Resistance
Eligibility:
FEMALE
48+ years
Phase:
PHASE1
Brief Summary
Diabetes Mellitus (DM) is a major risk factor for cardiovascular disease, with 50% of diabetes-associated deaths being attributed to cardiovascular complications. The characterising features of DM inc...
Detailed Description
The prevalence of type 2 DM and related-complications continues to increase. Diet is a significant factor in the aetiology of type 2 DM. Intakes of zinc and omega 3 fatty acids may modulate glycaemic ...
Eligibility Criteria
Inclusion
- Female, postmenopausal
- Type 2 diabetes (controlled by diet and lifestyle; or oral hypoglycaemic medication (i.e. metformin) for not more than 7 years)
- Normal Glomerular Filtration Rate (GFR) and normal microalbumin/creatine ratio
- No nutritional supplements in the 6 weeks prior to the trial \& continuing through the trial period
- Non-smoking
Exclusion
- Diagnosed with current major illness (renal disease, significant cardiovascular disease, gastrointestinal disorders, cancer, or other significant disorder likely to interfere with zinc metabolism)
- Taking medications that are likely to interfere with zinc metabolism
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01505803
Start Date
July 1 2010
End Date
December 1 2011
Last Update
January 9 2012
Active Locations (1)
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1
University of Sydney
Sydney, New South Wales, Australia, 2006