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Clinical Trials/NCT02383784
NCT02383784
Completed
Not Applicable

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

Federal University of Vicosa1 site in 1 country18 target enrollmentMarch 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Federal University of Vicosa
Enrollment
18
Locations
1
Primary Endpoint
Body fat content determined by tetrapolar bioelectrical impedance .
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
December 2007
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Vicosa
Responsible Party
Principal Investigator
Principal Investigator

Dr Junia Maria Geraldo Gomes

MSc

Federal University of Vicosa

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Body fat content determined by tetrapolar bioelectrical impedance .

Time Frame: 30 days

Study Sites (1)

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