Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-glycemic index | Experimental | Low-glycemic index lunches and dinners (<55%) |
|
| Control | Active Comparator | Medium/high glycemic index lunches and dinners (>60%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-glycemic index | Other | Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Fasting glycemia at 12 weeks | Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks | 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 | up to 12 weeks |
| Change from Baseline Glycosylated hemoglobin at 12 weeks | Glycosylated hemoglobin was measured at Baseline and at 12 weeks | up to 12 weeks |
| Change from Baseline Triglycerides at 12 weeks | Triglycerides (mg/dL) was measured at Baseline and at 12 weeks | 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 | up to 12 weeks |
| Change from Baseline HDL cholesterol at 12 weeks | HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks | up to 12 weeks |
| Change from Baseline Total cholesterol at 12 weeks | Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks | up to 12 weeks |
| Change from Baseline LDL cholesterol at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) | Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks. | up to 12 weeks |
| Waist circumference | Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control | Other | Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively. |
|
LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks |
| up to 12 weeks |
| 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 | 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 | 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 | 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 | up to 12 weeks |
| Subjective satiety | Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject | 7 days |
| Objective satiety | 24-hour recall was applied the same 7 days as the VAS to each subject | 7 days |
| up to 12 weeks |
| Alcohol intake | Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks. | up to 12 weeks |
| Physical activity | Physical activity was measured at Baseline, 4, 8 and 12 weeks. | 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). | up to 12 weeks |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |