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临床试验/NCT02383784
NCT02383784已完成不适用

Effects of Low- or High-glycemic Index Diets in Metabolic and Inflammatory Responses in Type 2 Diabetics

Federal University of Vicosa2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2007年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Body fat content determined by tetrapolar bioelectrical impedance .

研究概览

简要总结

Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged 42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30 consecutive days. The other meals were consumed under free living condition and subjects were instructed to select foods presenting GI values corresponding to the allocated group. Body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake was monitored during the study. The criterion for statistical significance was P<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes mellitus
  • Level of physical activity light to moderate
  • Use of sulfonylureas or biguanides oral hypoglycemic drugs
  • Stable medications for the previous 3 months

排除标准

  • Cardiovascular, renal, or liver disease
  • Treatment for cancer
  • Daily consumption of > 50g/day of alcohol
  • Pregnant, lactating, postmenopausal women,
  • Hormone replacement therapy
  • Recent change (last three months) in the level of physical activity or diet
  • Weight instability (> 3 kg in the previous three months),
  • Therapeutic diet
  • Allergies, test foods intolerance
  • Use of drugs affecting body metabolism and/or food intake.

研究组 & 干预措施

Low-GI diet

Experimental

Low glycemic index diet

干预措施: Low GI index diet (Dietary Supplement)

High-GI diet

Experimental

High glycemic index diet

干预措施: High GI diet (Dietary Supplement)

结局指标

主要结局

Body fat content determined by tetrapolar bioelectrical impedance .

时间窗: 30 days

次要结局

未报告次要终点

研究者

发起方
Federal University of Vicosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Junia Maria Geraldo Gomes

MSc

Federal University of Vicosa

研究点 (2)

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