Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E on Insulin Sensitivity, Beta Cell Function, Markers of Inflammation, Body Fat Mass and Other Biochemical Indicators in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- insulin sensitivity
研究概览
简要总结
Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2 form. Observations clearly emphasize that differences exist between mammalian species in their response to CLAs with mice being the most sensitive. The majority of studies on body compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease attenuation, on insulin sensitivity and diabetes and on immune function have been conducted with a variety of animal models. Recent studies indicate that some but not all of the effects observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer. Suggestions of possible deleterious effects in man due to an increase in oxidative lipid products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation. Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt on their physiological relevance. We hypothesized that supplementation with CLA + an antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on glycemic control and insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus > 5 years
- •HbA1c ≤ 9%
- •Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2)
- •Age ≥ 30 and ≤ 70 years (postmenopausal if female)
- •Stable medical therapy for past 3 months
- •Stable serum glucose for past 3 months (128-180 mg/Dl)
- •Age between 30 to 50
- •Use of metformin
- •TG < 240 mg/Dl
- •No alcohol, no insulin, no smoke
- •No pregnancy, no menopause
排除标准
- •Personal history of coronary heart disease
- •Cerebrovascular disease or vascular disease
- •Renal or hepatic disease
- •Inflammatory diseases and thyroid diseases within the last years
- •Use of drugs known to affect glycemic control, beta blockers, any change in daily activity profile, and diet
结局指标
主要结局
insulin sensitivity
beta cell function
glycosylated hemoglobin
次要结局
- inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
- systolic and diastolic blood pressure
- serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
- fibrinogen, PAI-1
- body fat using bioimpedance
- oxidative stress (MDA)
