Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Low-glycemic index
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-glycemic index<br>Low-glycemic index lunches and dinners (<55%) | Other: Low-glycemic index<br>* Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.<br>|
| Active Comparator: Control<br>Medium/high glycemic index lunches and dinners (>60%) | Other: Control<br>* Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLYCEMIC INDEX, NAFLD, METABOLIC PARAMETERS, SATIETY