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NCT Number: NCT01738802

The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes

This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes. The investigators hypothesize that daily supplementation with a multiple micronutrient formulation containing dietary and endogenous antioxidants in combination with usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

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About this study

This study is evaluating the impact of an antioxidant and micronutrient supplement on markers of oxidative stress and inflammation as well as on blood sugar control in adults over the age of 50 who have had Type 2 diabetes for at least 3 months. The purpose of this study is to see if these antioxidants reduce the oxidative and inflammatory state seen in patients with Type 2 diabetes as well as whether or not they make it easier to control blood sugar, affect the number and dosage of diabetic medications, and/or reduce the risk factors involved in long-term diabetes related complications such as in lipid profile and carotid intima-media thickness (CIMT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of Type 2 diabetes of at least three months duration
  • 50 years of age or older
  • Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
  • Not taking or not expected to be taking any oral glucocorticoids (except for replacement therapy for those with adrenal insufficiency), amphetamines, anabolic, or weight-reducing agents during the course of the study
  • Not receiving chemotherapy or immunosuppressive therapy
  • Military healthcare beneficiary

Exclusion criteria

  • Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months duration.
  • Inability to communicate in written and spoken English
  • Organ (kidney, pancreas, liver) transplant recipients
  • Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
  • Pregnancy (Women who are pre-menopausal will be informed that pregnancy must be ruled out by a serum HCG test if they would like to be considered for participation in the study. Women who have had a hysterectomy or have not had a menstrual period for at least one year prior to consent will be considered post-menopausal and will not require a serum pregnancy test).
  • Patients who are routinely taking more than 81 mg aspirin (ASA)/day or who are using ASA or ASA-containing products to manage a chronic condition.

Treatment and study plan

Anti-oxidant and micronutrient

Dietary Supplement

This group will be randomized to take the anti-oxidant and micronutrient supplement.

Placebo

Drug

This group will take a placebo.

Primary outcomes

  1. Change in the markers of oxidative stress and inflammation

    Time frame: baseline, 6, and 12 months

    Determining a difference between the control and experimental groups in the following markers of 1) oxidative stress: 9-Malondialdehyde (MDA) in plasma, 3-Nitrotyrosine in plasma, and Urinary levels of F2-isoprostane and 8 hydroxy,deoxyguanosine; and 2) inflammation: GM-CSF, IFN-γ, IL-1β, IL-2, L-4, IL-5, IL-6, IL-10, IL-12 (p40/p70), TNF-α.

Secondary outcomes

  1. Change in CIMT

    Time frame: Baseline, 6 and 12 months

    Determine if a difference exists in CIMT measurements between the control and experimental groups.

  2. Change in medications

    Time frame: Baseline, 3, 6, 9, and 12 months

    Compare the experimental and control groups to determine if medication use has changed over the course of the study.

  3. Change in lipid profile

    Time frame: baseline, 3, 6, 9, and 12 months

    Compare the control and experimental groups to determine differences in lipid profile over time.

  4. Hemoglobin A1c

    Time frame: baseline, 3, 6, 9, and 12 months

    Determine the difference in quarterly A1c measurements between the experimental and control groups over the course of the study.

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

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Registry information

Acronym: PMC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2012
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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