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Completed

NCT Number: NCT02383784

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolism and body composition laboratory, Federal University of Vicosa

Viçosa, Minas Gerais, 36570-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low GI index diet

Dietary Supplement

Low glycemic index diet

High GI diet

Dietary Supplement

High glycemic index diet

Primary outcomes

  1. Body fat content determined by tetrapolar bioelectrical impedance .

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Federal University of Vicosa

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 9, 2015
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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