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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low GI index diet
High GI diet
Sponsored by
Federal University of Vicosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Metabolism and body composition laboratory, Federal University of Vicosa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-GI diet

High-GI diet

Arm Description

Low glycemic index diet

High glycemic index diet

Outcomes

Primary Outcome Measures

Body fat content determined by tetrapolar bioelectrical impedance .

Secondary Outcome Measures

Full Information

First Posted
February 26, 2015
Last Updated
March 3, 2015
Sponsor
Federal University of Vicosa
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02383784
Brief Title
Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics
Official Title
Effects of Low- or High-glycemic Index Diets in Metabolic and Inflammatory Responses in Type 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Vicosa
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-GI diet
Arm Type
Experimental
Arm Description
Low glycemic index diet
Arm Title
High-GI diet
Arm Type
Experimental
Arm Description
High glycemic index diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Low GI index diet
Intervention Description
Low glycemic index diet
Intervention Type
Dietary Supplement
Intervention Name(s)
High GI diet
Intervention Description
High glycemic index diet
Primary Outcome Measure Information:
Title
Body fat content determined by tetrapolar bioelectrical impedance .
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
Metabolism and body composition laboratory, Federal University of Vicosa
City
Vicosa
State/Province
Minas Gerais
ZIP/Postal Code
36570-000
Country
Brazil

12. IPD Sharing Statement

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

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