Effect of Low-glycemic Index Lunches and Dinners Intake on Indicators of Satiety, Metabolic Parameters and Liver Steatosis Degree on Women With Type 2 Diabetes Under Metformin Therapy: Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Change from Baseline Fasting glycemia at 12 weeks
研究概览
简要总结
To compare the effect of low-glycemic index versus control lunches and dinners intake on indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2 diabetes under metformin therapy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjets with type 2 diabetes mellitus diagnosis under metformin therapy.
- •Female sex.
- •Aged 30 to 65 years.
- •Body Mass Index (BMI) 22 to 34.9 kg / m2.
排除标准
- •Women with insulin-releasing drugs or insulin treatment.
- •Patients with diabetic nephropathy, retinopathy, chronic kidney disease, stroke.
- •Subjects with hypothyroidism without treatment.
- •Individuals with food allergies or intolerances.
- •Women who present an intake of ≥20 g of alcohol per day quantified through a closed consumption frequency survey.
- •Patients with previously diagnosed hepatitis, hepatic cirrhosis or liver cancer.
结局指标
主要结局
Change from Baseline Fasting glycemia at 12 weeks
时间窗: up to 12 weeks
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Total cholesterol/HDL ratio at 12 weeks
时间窗: up to 12 weeks
Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks
Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks
时间窗: up to 12 weeks
High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks
Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
时间窗: up to 12 weeks
Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Subjective satiety
时间窗: 7 days
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
Postprandial glycemia
时间窗: up to 12 weeks
Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks
Change from Baseline Triglycerides at 12 weeks
时间窗: up to 12 weeks
Triglycerides (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Liver steatosis degree at 12 weeks
时间窗: up to 12 weeks
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
Change from Baseline Glycosylated hemoglobin at 12 weeks
时间窗: up to 12 weeks
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
Change from Baseline HDL cholesterol at 12 weeks
时间窗: up to 12 weeks
HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Total cholesterol at 12 weeks
时间窗: up to 12 weeks
Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Objective satiety
时间窗: 7 days
24-hour recall was applied the same 7 days as the VAS to each subject
Change from Baseline LDL cholesterol at 12 weeks
时间窗: up to 12 weeks
LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
时间窗: up to 12 weeks
Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks
次要结局
- Alcohol intake(up to 12 weeks)
- Adherence to treatment(up to 12 weeks)
- Body mass index (BMI)(up to 12 weeks)
- Waist circumference(up to 12 weeks)
- Physical activity(up to 12 weeks)
研究者
Claudia Vega Soto
Nutritionist
Universidad de Valparaiso