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

This study is currently recruiting participants.
Verified December 2012 by Walter Reed National Military Medical Center
Sponsor:
Information provided by (Responsible Party):
Robert Vigersky, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01738802
First received: July 19, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Dietary Supplement: Anti-oxidant and micronutrient

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Change in the markers of oxidative stress and inflammation [ Time Frame: baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in CIMT [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
    Determine if a difference exists in CIMT measurements between the control and experimental groups.

  • Change in medications [ Time Frame: Baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Compare the experimental and control groups to determine if medication use has changed over the course of the study.

  • Change in lipid profile [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Compare the control and experimental groups to determine differences in lipid profile over time.

  • Hemoglobin A1c [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Determine the difference in quarterly A1c measurements between the experimental and control groups over the course of the study.


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-oxidant and micronutrient
This group will take the anti-oxidant and micronutrient supplement.
 Dietary Supplement: Anti-oxidant and micronutrient
This group will be randomized to take the anti-oxidant and micronutrient supplement.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of Type 2 diabetes of at least three months duration
  2. 50 years of age or older
  3. Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
  4. 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
  5. Not receiving chemotherapy or immunosuppressive therapy
  6. Military healthcare beneficiary

Exclusion Criteria:

  1. Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months duration.
  2. Inability to communicate in written and spoken English
  3. Organ (kidney, pancreas, liver) transplant recipients
  4. 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
  5. 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).
  6. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738802

Contacts
Contact: Sara Salkind 301-319-2873 sara.salkind@med.navy.mil
Contact: Sheri Senicki 301-319-3402 sheri.senicki@med.navy.mil

Locations
United States, Maryland
Walter Reed National Military Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889-5600
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Sara J Salkind, MA     301-319-2873     sara.j.salkind.ctr@health.mil    
Contact: Susan M Walker, PhD     301-319-2867     susan.walker@us.army.mil    
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
Principal Investigator: Robert Vigersky, MD WRNMMC
  More Information

No publications provided

Responsible Party: Robert Vigersky, COL, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01738802     History of Changes
Other Study ID Numbers: 361813
Study First Received: July 19, 2012
Last Updated: December 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Walter Reed National Military Medical Center:
Type 2 Diabetes
carotid intima medial thickness
micronutrient
anti-oxidant

Additional relevant MeSH terms:
Antioxidants
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Micronutrients
 Trace Elements
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013