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

NCT03165877 | Completed DMC

• 1 other identifier: 035-2013
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

GLYCEMIC INDEX; NAFLD; METABOLIC PARAMETERS; SATIETY

Outcome Measures

Primary Outcomes (14)

• Change from Baseline Fasting glycemia at 12 weeks

  Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks

  up to 12 weeks

• 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

• Change from Baseline Glycosylated hemoglobin at 12 weeks

  Glycosylated hemoglobin was measured at Baseline and at 12 weeks

  up to 12 weeks

• Change from Baseline Triglycerides at 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

  Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks

  up to 12 weeks

• Change from Baseline HDL cholesterol at 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

  Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks

  up to 12 weeks

• Change from Baseline LDL cholesterol at 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

  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

  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

  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

  Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks

  up to 12 weeks

• Subjective satiety

  Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject

  7 days

• Objective satiety

  24-hour recall was applied the same 7 days as the VAS to each subject

  7 days

Secondary Outcomes (5)

• Body mass index (BMI)

  up to 12 weeks

• Waist circumference

  up to 12 weeks

• Alcohol intake

  up to 12 weeks

• Physical activity

  up to 12 weeks

• Adherence to treatment

  up to 12 weeks

Study Arms (2)

Low-glycemic index

EXPERIMENTAL

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

Other: Low-glycemic index

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Low-glycemic index OTHER

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

Low-glycemic index

Control OTHER

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

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Valparaiso: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: May 24, 2017
• Study Start: May 31, 2016
• Primary Completion: October 13, 2016
• Study Completion: October 13, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share