The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change in the markers of oxidative stress and inflammation
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Anti-oxidant and micronutrient
This group will take the anti-oxidant and micronutrient supplement.
干预措施: Anti-oxidant and micronutrient (Dietary Supplement)
Placebo
This group will take the placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the markers of oxidative stress and inflammation
时间窗: baseline, 6, and 12 months
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.
次要结局
- Change in medications(Baseline, 3, 6, 9, and 12 months)
- Hemoglobin A1c(baseline, 3, 6, 9, and 12 months)
- Change in lipid profile(baseline, 3, 6, 9, and 12 months)
- Change in CIMT(Baseline, 6 and 12 months)
研究者
Alicia L. Warnock
Director, Diabetes Institute
Walter Reed National Military Medical Center