Diabetes Mellitus, Type 2
Conditions
Keywords
GLYCEMIC INDEX, NAFLD, METABOLIC PARAMETERS, SATIETY
Brief summary
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.
Interventions
OTHERLow-glycemic index
Subjects ate low-glycemic index lunches and dinners (\<55%),consisting of salad, main course and dessert, respectively.
OTHERControl
Subjects ate standard lunches and dinners (\>60%),consisting of salad, main course and dessert, respectively.
Sponsors
Universidad de Valparaiso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective satiety | 7 days | 24-hour recall was applied the same 7 days as the VAS to each subject |
| Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks | up to 12 weeks | High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks |
| Change from Baseline Aspartate aminotransferase (AST) at 12 weeks | up to 12 weeks | Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks |
| Change from Baseline Alanine aminotransferase (ALT) at 12 weeks | up to 12 weeks | Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks |
| Change from Baseline Liver steatosis degree at 12 weeks | up to 12 weeks | Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks |
| Subjective satiety | 7 days | Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject |
| Change from Baseline Fasting glycemia at 12 weeks | up to 12 weeks | Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks |
| Postprandial glycemia | 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 Glycosylated hemoglobin at 12 weeks | up to 12 weeks | Glycosylated hemoglobin was measured at Baseline and at 12 weeks |
| Change from Baseline Triglycerides at 12 weeks | up to 12 weeks | Triglycerides (mg/dL) was measured at Baseline and at 12 weeks |
| Change from Baseline Total cholesterol/HDL ratio at 12 weeks | up to 12 weeks | Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks |
| Change from Baseline HDL cholesterol at 12 weeks | up to 12 weeks | HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks |
| Change from Baseline Total cholesterol at 12 weeks | up to 12 weeks | Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks |
| Change from Baseline LDL cholesterol at 12 weeks | up to 12 weeks | LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | up to 12 weeks | Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks. |
| Waist circumference | up to 12 weeks | Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks. |
| Physical activity | up to 12 weeks | Physical activity was measured at Baseline, 4, 8 and 12 weeks. |
| Adherence to treatment | up to 12 weeks | 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). |
| Alcohol intake | up to 12 weeks | Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks. |
Outcome results
None listed