Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Effect of a Nutritional Supplement on Cardiometabolic, Inflammatory, and Oxidative Stress Markers in Individuals With Type 2 Diabetes Mellitus: a Pilot Study
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 include: the presence of chronic hyperglycaemia, consequent upon decreased secretion or action of insulin; dyslipidaemia; and enhanced levels of oxidative stress and inflammation. Zinc and omega 3 polyunsaturated fatty acids have been shown to influence each of these outcomes via several mechanisms. This pilot study will examine the effect of nutritional supplements containing zinc and omega 3 on these outcomes in a population with type 2 DM.
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 control, lipid metabolism, and inflammatory processes in the disease.
Zinc is involved in many biological processes that include enzyme action, stabilisation of
cell membranes, regulation of gene expression, and cell signalling. Zinc supplementation has
been demonstrated to improve glycaemic control in both animals and humans. The normalising
effect of zinc on glucose homeostasis may relate to its involvement in insulin metabolism.
Zinc functions in the synthesis, storage, secretion, and action of insulin. Omega-3 also
enhances glycaemic control and dietary supplementation with omega-3 polyunsaturated fatty
acids has been shown to improve insulin sensitivity in subjects with DM. Both zinc and
omega-3 function to mediate lipid metabolism. Zinc supplementation has been found to be
associated with a beneficial increase in HDL cholesterol concentrations in individuals with
type 2 DM. The mechanism may again involve insulin, which has been proposed as an
independent predictor of plasma HDL. Omega-3 directly activates transcription factors that
regulate lipid metabolism and is known to decrease serum triglyceride levels in DM. Zinc
appears to beneficially impact oxidative stress-related parameters in DM via a range of
mechanisms, including the regulation of copper,zinc superoxide dismutase, metallothionein,
NF-κB and nitric oxide signaling. The purpose of this pilot study is to explore the effect
of zinc and omega 3 supplementation on hyperglycaemia, dyslipidaemia, chronic inflammation,
and oxidative stress in a population with type 2 DM.
This study will recruit 48 postmenopausal women with type 2 DM. Participants will be
randomly allocated to one of 4 groups for a period of 12 weeks: placebo, zinc, omega 3, or
zinc + omega 3 supplementation. Usual dietary intake will be assessed before and after the
trial period using 2-day estimated food records, which will be checked by a research
dietitian. Blood samples will be collected from all participants at the start of the
intervention (week 0) then at 4 weekly intervals (weeks 4, 8, 12) by qualified
phlebotomists. Blood samples will be analysed for plasma zinc, plasma lipids and fatty
acids, markers of inflammation and oxidative stress, and indicators of glycaemic control. An
aliquot of blood will also be used for the measurement of zinc transporter mRNA levels
utilising real-time quantitative PCR techniques.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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