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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
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 20, 2017
    Last Updated
    May 22, 2017
    Sponsor
    Universidad de Valparaiso
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    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

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

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