The Effect of a Nutritional Supplement in Individuals With Type 2 Diabetes Mellitus: a Pilot Study

NCT01505803 | Completed Phase 1

• 1 other identifier: HREC 12392
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Keywords

Type 2 diabetes mellitus; Dietary supplements; Hyperglycemia; Insulin resistance; Dyslipidemia; Inflammation; Oxidative stress; Zinc; Omega 3

Outcome Measures

Primary Outcomes (3)

• Plasma lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

  12 weeks

• Glycaemic control (glucose, insulin, HbA1c)

  12 weeks

• Inflammation & oxidative stress (CRP, TNF-α, IL-1, IL-2, IL-6, IL-10 F2 isoprostanes, NF-κB, MPO, other)

  12 weeks

Secondary Outcomes (3)

• Zinc transporter mRNA expression in peripheral blood mononuclear cells

  12 weeks

• Plasma zinc

  12 weeks

• Plasma fatty acids

  12 weeks

Study Arms (4)

Zinc supplement

ACTIVE COMPARATOR

Dietary Supplement: Zinc supplements; Dietary Supplement: Placebo supplements

Omega 3 supplement

ACTIVE COMPARATOR

Dietary Supplement: Omega 3 supplements; Dietary Supplement: Placebo supplements

Zinc and omega 3 supplements

ACTIVE COMPARATOR

Dietary Supplement: Zinc supplements; Dietary Supplement: Omega 3 supplements

Placebo supplement

PLACEBO COMPARATOR

Dietary Supplement: Placebo supplements

Interventions

Zinc supplements DIETARY_SUPPLEMENT

Participants will receive 40 mg of zinc each day for 12 weeks.

Zinc and omega 3 supplements; Zinc supplement

Omega 3 supplements DIETARY_SUPPLEMENT

Participants will receive 2 g of omega 3 fatty acids each day for 12 weeks.

Omega 3 supplement; Zinc and omega 3 supplements

Placebo supplements DIETARY_SUPPLEMENT

Participants will receive placebo supplements each day for 12 weeks.

Omega 3 supplement; Placebo supplement; Zinc supplement

Eligibility Criteria

• Age: 48 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

Related Publications (3)

• Foster M, Petocz P, Samman S. Effects of zinc on plasma lipoprotein cholesterol concentrations in humans: a meta-analysis of randomised controlled trials. Atherosclerosis. 2010 Jun;210(2):344-52. doi: 10.1016/j.atherosclerosis.2009.11.038. Epub 2009 Nov 29.

  PMID: 20034629 BACKGROUND

• Foster M, Samman S. Zinc and redox signaling: perturbations associated with cardiovascular disease and diabetes mellitus. Antioxid Redox Signal. 2010 Nov 15;13(10):1549-73. doi: 10.1089/ars.2010.3111.

  PMID: 20568953 BACKGROUND

• Foster M, Hancock D, Petocz P, Samman S. Zinc transporter genes are coordinately expressed in men and women independently of dietary or plasma zinc. J Nutr. 2011 Jun;141(6):1195-201. doi: 10.3945/jn.111.140053. Epub 2011 Apr 13.

  PMID: 21490290 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Hyperglycemia; Dyslipidemias; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Lipid Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir Samman

  University of Sydney

  PRINCIPAL INVESTIGATOR

• Meika Foster

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: January 9, 2012
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01

Locations

AU (1)