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

NCT ID: NCT03165877

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-13

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Low-glycemic index

Low-glycemic index lunches and dinners (\<55%)

Group Type EXPERIMENTAL

Low-glycemic index

Intervention Type OTHER

Subjects ate low-glycemic index lunches and dinners (\<55%),consisting of salad, main course and dessert, respectively.

Control

Medium/high glycemic index lunches and dinners (\>60%)

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Subjects ate standard lunches and dinners (\>60%),consisting of salad, main course and dessert, respectively.

Interventions

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Low-glycemic index

Subjects ate low-glycemic index lunches and dinners (\<55%),consisting of salad, main course and dessert, respectively.

Intervention Type OTHER

Control

Subjects ate standard lunches and dinners (\>60%),consisting of salad, main course and dessert, respectively.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Valparaiso

OTHER

Sponsor Role lead

Responsible Party

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Claudia Vega Soto

Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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035-2013

Identifier Type: -

Identifier Source: org_study_id

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