The Effects of Different Acute Nutritional Protocols and Lifestyle Modification on Circulating L-arginine and Asymmetric Dimethylarginine (ADMA) in Obese and Type 2 Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- High asymmetric dimethylarginine (ADMA) change
研究概览
简要总结
Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/ obese and T2DM subjects.
详细描述
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obese and/ or T2DM subjects
排除标准
- •type 1 diabetes
- •insulin-treated T2DM
- •active coronary disease (recent [≤ 6months] myocardial infarction, unstable angina, recent coronary catheterization, or coronary bypass grafting
- •individuals with significant impairment in liver enzymes (≥ 2.5 the upper limit of the normal range)
- •serum creatinine higher than 1.5mg%
- •known malabsorption, alcoholism or illicit use of drugs
- •abnormal thyroid function tests
- •concomitant or recent use of glucocorticoids
- •uncertain mental state (to avoid invalid informed consent or lack of compliance).
研究组 & 干预措施
Acute glucose tolerance test
A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)
干预措施: Acute dietary protocols and lifestyle modification (Behavioral)
Acute protein load test
A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is
干预措施: Acute dietary protocols and lifestyle modification (Behavioral)
Acute fat load test
a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat
干预措施: Acute dietary protocols and lifestyle modification (Behavioral)
Acute alcohol load test
Vodka (100 cc, 40% alcohol)
干预措施: Acute dietary protocols and lifestyle modification (Behavioral)
Acute exercise
30 minutes of supervised graded walking on a treadmill according to each subject's individual ability. A goal heart rate was calculated as 70% of the age-adjusted maximal allowable heart rate.
干预措施: Acute dietary protocols and lifestyle modification (Behavioral)
Lifestyle modification program - 12 weeks
12 weeks of weight-loss dietary program constructed according to the guidelines of the American Diabetes Association. Based on weight, gender, and age, daily dietary allowance varied at 1200-1800 Kcal, 50% carbohydrates, 20% protein, and 30% fat. Participants were also asked to engage in moderate physical activity comprised of a 40-minute walk three times a week. A weekly clinic visit alternating with a weekly telephone contact was also required.
干预措施: Acute dietary protocols and lifestyle modification (Behavioral)
结局指标
主要结局
High asymmetric dimethylarginine (ADMA) change
时间窗: For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase
Change in ADMA levels (absolute and relative) (µmol/l)
Serum L-arginine change
时间窗: For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase
Change in arginine levels (absolute and relative) (µmol/l)
次要结局
- Glycated hemoglobin (HbA1c) change(From baseline to 12 weeks for lifestyle modification phase)
- Body mass index (BMI) change(From baseline to 12 weeks for lifestyle modification phase)