The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
Completed · Not applicable · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT01738802
- Run by
- Walter Reed National Military Medical Center
- People needed
- 111
- Starts
- 2012-01-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-04-28
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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.
Where it is running
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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