Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Low GI index diet; Dietary Supplement: High GI diet

• Registration Number: NCT02383784
• Lead Sponsor: Federal University of Vicosa

Brief Summary

Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged 42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30 consecutive days. The other meals were consumed under free living condition and subjects were instructed to select foods presenting GI values corresponding to the allocated group. Body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake was monitored during the study. The criterion for statistical significance was P\<0.05.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-03
• Study Completion: 2007-12
• Study First Submitted: 2015-02-26
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-03
• Last Update Submitted: 2015-03-03
• Study First Posted: 2015-03-09
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Type 2 diabetes mellitus
• Level of physical activity light to moderate
• Use of sulfonylureas or biguanides oral hypoglycemic drugs
• Stable medications for the previous 3 months

Exclusion Criteria

• Cardiovascular, renal, or liver disease
• Treatment for cancer
• Smokers
• Daily consumption of > 50g/day of alcohol
• Pregnant, lactating, postmenopausal women,
• Hormone replacement therapy
• Recent change (last three months) in the level of physical activity or diet
• Weight instability (> 3 kg in the previous three months),
• Therapeutic diet
• Allergies, test foods intolerance
• Use of drugs affecting body metabolism and/or food intake.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-GI diet	Low GI index diet	Low glycemic index diet
High-GI diet	High GI diet	High glycemic index diet

Primary Outcome Measures

Name	Time	Method
Body fat content determined by tetrapolar bioelectrical impedance .	30 days

Trial Locations

Locations (1)

Metabolism and body composition laboratory, Federal University of Vicosa; 🇧🇷 Vicosa, Minas Gerais, Brazil