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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Low GI index diet
* Dietary Supplement: High GI diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-GI diet<br>Low glycemic index diet | Dietary Supplement: Low GI index diet<br>* Low glycemic index diet<br>|
| Experimental: High-GI diet<br>High glycemic index diet | Dietary Supplement: High GI diet<br>* High glycemic index diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat content determined by tetrapolar bioelectrical impedance . |  | 30 days |