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

NCT01738802 | Completed DMC

• 1 other identifier: 361813
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; carotid intima medial thickness; micronutrient; anti-oxidant

Outcome Measures

Primary Outcomes (1)

• Change in the markers of oxidative stress and inflammation

  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.

  baseline, 6, and 12 months

Secondary Outcomes (4)

• Change in CIMT

  Baseline, 6 and 12 months

• Change in medications

  Baseline, 3, 6, 9, and 12 months

• Change in lipid profile

  baseline, 3, 6, 9, and 12 months

• Hemoglobin A1c

  baseline, 3, 6, 9, and 12 months

Study Arms (2)

Anti-oxidant and micronutrient

EXPERIMENTAL

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

Dietary Supplement: Anti-oxidant and micronutrient

Placebo

PLACEBO COMPARATOR

This group will take the placebo.

Drug: Placebo

Interventions

Anti-oxidant and micronutrient DIETARY_SUPPLEMENT

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

Anti-oxidant and micronutrient

Placebo DRUG

This group will take a placebo.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of Type 2 diabetes of at least three months duration
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Antioxidants; Micronutrients

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Robert Vigersky, MD

  WRNMMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetes Institute

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: November 30, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

US (2)