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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13
Subjects ate low-glycemic index lunches and dinners (\<55%),consisting of salad, main course and dessert, respectively.
Subjects ate standard lunches and dinners (\>60%),consisting of salad, main course and dessert, respectively.
Change from Baseline Fasting glycemia at 12 weeks
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Postprandial glycemia
Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks
Time frame: up to 12 weeks
Change from Baseline Glycosylated hemoglobin at 12 weeks
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline Triglycerides at 12 weeks
Triglycerides (mg/dL) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline Total cholesterol/HDL ratio at 12 weeks
Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline HDL cholesterol at 12 weeks
HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline Total cholesterol at 12 weeks
Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline LDL cholesterol at 12 weeks
LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
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Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks
High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Time frame: up to 12 weeks
Change from Baseline Liver steatosis degree at 12 weeks
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
Time frame: up to 12 weeks
Subjective satiety
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
Time frame: 7 days
Objective satiety
24-hour recall was applied the same 7 days as the VAS to each subject
Time frame: 7 days
Body mass index (BMI)
Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.
Time frame: up to 12 weeks
Waist circumference
Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.
Time frame: up to 12 weeks
Alcohol intake
Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.
Time frame: up to 12 weeks
Physical activity
Physical activity was measured at Baseline, 4, 8 and 12 weeks.
Time frame: up to 12 weeks
Adherence to treatment
The percentage of adherence to treatment was measured through a daily survey for 12 weeks. It is the calculation of compliance with planned meals intake (number of lunches and dinners eaten / total number of lunches and dinners of the study x 100).
Time frame: up to 12 weeks