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

May 22, 2017 updated by: Claudia Vega Soto, Universidad de Valparaiso

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Fasting glycemia at 12 weeks
Time Frame: up to 12 weeks
Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks
up to 12 weeks
Postprandial glycemia
Time Frame: up to 12 weeks
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
Time Frame: up to 12 weeks
Glycosylated hemoglobin was measured at Baseline and at 12 weeks
up to 12 weeks
Change from Baseline Triglycerides at 12 weeks
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 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
Time Frame: up to 12 weeks
Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks
up to 12 weeks
Subjective satiety
Time Frame: 7 days
Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject
7 days
Objective satiety
Time Frame: 7 days
24-hour recall was applied the same 7 days as the VAS to each subject
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: up to 12 weeks
Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.
up to 12 weeks
Waist circumference
Time Frame: up to 12 weeks
Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.
up to 12 weeks
Alcohol intake
Time Frame: up to 12 weeks
Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.
up to 12 weeks
Physical activity
Time Frame: up to 12 weeks
Physical activity was measured at Baseline, 4, 8 and 12 weeks.
up to 12 weeks
Adherence to treatment
Time Frame: 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).
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Valparaiso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 035-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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