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

NCT02383784 | Completed DMC

• 1 other identifier: 40501156099
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Body fat content determined by tetrapolar bioelectrical impedance .

  30 days

Study Arms (2)

Low-GI diet

EXPERIMENTAL

Low glycemic index diet

Dietary Supplement: Low GI index diet

High-GI diet

EXPERIMENTAL

High glycemic index diet

Dietary Supplement: High GI diet

Interventions

Low GI index diet DIETARY_SUPPLEMENT

Low glycemic index diet

Low-GI diet

High GI diet DIETARY_SUPPLEMENT

High glycemic index diet

High-GI diet

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Vicosa: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Metabolism and body composition laboratory, Federal University of Vicosa

Viçosa, Minas Gerais, 36570-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 9, 2015
• Study Start: March 1, 2007
• Primary Completion: March 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

BR (1)