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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: Antioxidants; Micronutrients; Trace Elements

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.