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

NCT ID: NCT01738802

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-04-30

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.

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).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: TRIPLE

Study Groups

Anti-oxidant and micronutrient

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

Group Type: EXPERIMENTAL

Anti-oxidant and micronutrient

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

This group will take the placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This group will take a placebo.

Interventions

Anti-oxidant and micronutrient

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

This group will take a placebo.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Alicia L. Warnock

Director, Diabetes Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Vigersky, MD

Role: PRINCIPAL_INVESTIGATOR

WRNMMC

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

361813

Identifier Type: -

Identifier Source: org_study_id