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

Universidad de Valparaiso

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Low-glycemic index; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03165877

035-2013

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups

Low-glycemic index

Experimental group

Description:

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

Treatment:

Other: Low-glycemic index

Control

Active Comparator group

Description:

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

Treatment:

Other: Control