Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy (LGIM)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-glycemic index
Control
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GLYCEMIC INDEX, NAFLD, METABOLIC PARAMETERS, SATIETY
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-glycemic index
Control
Arm Description
Low-glycemic index lunches and dinners (<55%)
Medium/high glycemic index lunches and dinners (>60%)
Outcomes
Primary Outcome Measures
Change from Baseline Fasting glycemia at 12 weeks
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
Postprandial glycemia
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
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
Change from Baseline Triglycerides at 12 weeks
Triglycerides (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Total cholesterol/HDL ratio at 12 weeks
Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks
Change from Baseline HDL cholesterol at 12 weeks
HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline Total cholesterol at 12 weeks
Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Change from Baseline LDL cholesterol at 12 weeks
LDL cholesterol (mg/dL) was measured at Baseline and at 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
Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Change from Baseline Liver steatosis degree at 12 weeks
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
Subjective satiety
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
Objective satiety
24-hour recall was applied the same 7 days as the VAS to each subject
Secondary Outcome Measures
Body mass index (BMI)
Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.
Waist circumference
Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.
Alcohol intake
Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.
Physical activity
Physical activity was measured at Baseline, 4, 8 and 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03165877
Brief Title
Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy
Acronym
LGIM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
October 13, 2016 (Actual)
Study Completion Date
October 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
GLYCEMIC INDEX, NAFLD, METABOLIC PARAMETERS, SATIETY
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-glycemic index
Arm Type
Experimental
Arm Description
Low-glycemic index lunches and dinners (<55%)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Medium/high glycemic index lunches and dinners (>60%)
Intervention Type
Other
Intervention Name(s)
Low-glycemic index
Intervention Description
Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.
Primary Outcome Measure Information:
Title
Change from Baseline Fasting glycemia at 12 weeks
Description
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Postprandial glycemia
Description
Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Glycosylated hemoglobin at 12 weeks
Description
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Triglycerides at 12 weeks
Description
Triglycerides (mg/dL) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Total cholesterol/HDL ratio at 12 weeks
Description
Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline HDL cholesterol at 12 weeks
Description
HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Total cholesterol at 12 weeks
Description
Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline LDL cholesterol at 12 weeks
Description
LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks
Description
High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
Description
Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
Description
Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks
Time Frame
up to 12 weeks
Title
Change from Baseline Liver steatosis degree at 12 weeks
Description
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
Time Frame
up to 12 weeks
Title
Subjective satiety
Description
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
Time Frame
7 days
Title
Objective satiety
Description
24-hour recall was applied the same 7 days as the VAS to each subject
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Body mass index (BMI)
Description
Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.
Time Frame
up to 12 weeks
Title
Waist circumference
Description
Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.
Time Frame
up to 12 weeks
Title
Alcohol intake
Description
Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.
Time Frame
up to 12 weeks
Title
Physical activity
Description
Physical activity was measured at Baseline, 4, 8 and 12 weeks.
Time Frame
up to 12 weeks
Title
Adherence to treatment
Description
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).
Time Frame
up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy
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