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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165877
• Other study ID #: 035-2013
• Status: Completed
• Phase: N/A
• First received: May 20, 2017
• Last updated: May 22, 2017
• Start date: May 31, 2016
• Est. completion date: October 13, 2016

Study information

• Verified date: May 2017
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 13, 2016
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Low-glycemic index
Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.
• Control
Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Valparaiso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Fasting glycemia at 12 weeks	Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Postprandial glycemia	Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks	up to 12 weeks
Primary	Change from Baseline Glycosylated hemoglobin at 12 weeks	Glycosylated hemoglobin was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline Triglycerides at 12 weeks	Triglycerides (mg/dL) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline Total cholesterol/HDL ratio at 12 weeks	Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline HDL cholesterol at 12 weeks	HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline Total cholesterol at 12 weeks	Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline LDL cholesterol at 12 weeks	LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	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	up to 12 weeks
Primary	Change from Baseline Aspartate aminotransferase (AST) at 12 weeks	Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline Alanine aminotransferase (ALT) at 12 weeks	Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks	up to 12 weeks
Primary	Change from Baseline Liver steatosis degree at 12 weeks	Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks	up to 12 weeks
Primary	Subjective satiety	Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject	7 days
Primary	Objective satiety	24-hour recall was applied the same 7 days as the VAS to each subject	7 days
Secondary	Body mass index (BMI)	Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.	up to 12 weeks
Secondary	Waist circumference	Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.	up to 12 weeks
Secondary	Alcohol intake	Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.	up to 12 weeks
Secondary	Physical activity	Physical activity was measured at Baseline, 4, 8 and 12 weeks.	up to 12 weeks
Secondary	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).	up to 12 weeks