Clinical trial NCT03165877: Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: GLYCEMIC INDEX
NAFLD
METABOLIC PARAMETERS
SATIETY
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 13
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline Fasting glycemia at 12 weeks
timeFrame: up to 12 weeks
measure: Postprandial glycemia
timeFrame: up to 12 weeks
measure: Change from Baseline Glycosylated hemoglobin at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline Triglycerides at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline Total cholesterol/HDL ratio at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline HDL cholesterol at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline Total cholesterol at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline LDL cholesterol at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline Aspartate aminotransferase (AST) at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline Alanine aminotransferase (ALT) at 12 weeks
timeFrame: up to 12 weeks
measure: Change from Baseline Liver steatosis degree at 12 weeks
timeFrame: up to 12 weeks
measure: Subjective satiety
timeFrame: 7 days
measure: Objective satiety
timeFrame: 7 days
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: up to 12 weeks
measure: Waist circumference
timeFrame: up to 12 weeks
measure: Alcohol intake
timeFrame: up to 12 weeks
measure: Physical activity
timeFrame: up to 12 weeks
measure: Adherence to treatment
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References: