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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Low-glycemic index; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Valparaiso

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2016
• Primary Completion (ACTUAL): October 13, 2016
• Study Completion (ACTUAL): October 13, 2016

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (ACTUAL): May 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: NAFLD; SATIETY; GLYCEMIC INDEX; METABOLIC PARAMETERS
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 035-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO