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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Low-glycemic index; Other: Control

• Registration Number: NCT03165877
• Lead Sponsor: Universidad de Valparaiso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-31
• Primary Completion: 2016-10-13
• Study Completion: 2016-10-13
• Status Verified: 2017-05
• Study First Submitted: 2017-05-20
• Study First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-glycemic index	Low-glycemic index	Low-glycemic index lunches and dinners (\<55%)
Control	Control	Medium/high glycemic index lunches and dinners (\>60%)

Primary Outcome Measures

Name	Time	Method
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
Objective satiety	7 days	24-hour recall was applied the same 7 days as the VAS 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
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 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 Alanine aminotransferase (ALT) at 12 weeks	up to 12 weeks	Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Subjective satiety	7 days	Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
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 Triglycerides at 12 weeks	up to 12 weeks	Triglycerides (mg/dL) was measured at Baseline and at 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 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
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

Secondary Outcome Measures

Name	Time	Method
Alcohol intake	up to 12 weeks	Alcohol intake (g/day) 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).
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.