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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of Low- or High-glycemic Index Diets in Metabolic and Inflammatory Responses in Type 2 Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383784
• Other study ID #: 40501156099
• Status: Completed
• Phase: N/A
• First received: February 26, 2015
• Last updated: March 3, 2015
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2015
• Source: Federal University of Vicosa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee, Viçosa, MG, Brazil ':'
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Low GI index diet
Low glycemic index diet
• High GI diet
High glycemic index diet

Locations

Country	Name	City	State
Brazil	Metabolism and body composition laboratory, Federal University of Vicosa	Vicosa	Minas Gerais

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Vicosa	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat content determined by tetrapolar bioelectrical impedance .		30 days	No