- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383784
Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics
March 3, 2015 updated by: Dr Junia Maria Geraldo Gomes, Federal University of Vicosa
Effects of Low- or High-glycemic Index Diets in Metabolic and Inflammatory Responses in Type 2 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Vicosa, Minas Gerais, Brazil, 36570-000
- Metabolism and body composition laboratory, Federal University of Vicosa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-GI diet
Low glycemic index diet
|
Low glycemic index diet
|
Experimental: High-GI diet
High glycemic index diet
|
High glycemic index diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body fat content determined by tetrapolar bioelectrical impedance .
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
February 26, 2015
First Submitted That Met QC Criteria
March 3, 2015
First Posted (Estimate)
March 9, 2015
Study Record Updates
Last Update Posted (Estimate)
March 9, 2015
Last Update Submitted That Met QC Criteria
March 3, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40501156099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
-
Newsoara Biopharma Co., Ltd.RecruitingT2DM (Type 2 Diabetes Mellitus)China
-
Shanghai Golden Leaf MedTec Co. LtdActive, not recruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Low GI index diet
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Diseases | OverweightUnited States
-
University Hospital of the West IndiesCompletedInflammation | Cardiovascular Disease | Type 2 DiabetesJamaica
-
National University Hospital, SingaporeNational Medical Research Council (NMRC), SingaporeUnknownType 2 Diabetes MellitusSingapore
-
Ohio State UniversityRecruitingGlucose Metabolism Disorders | Spinal Cord Injuries | Postprandial HypotensionUnited States
-
University of TorontoCanadian Institutes of Health Research (CIHR); Canadian Diabetes Association; Canadian Foundation for Dietetic Research (CFDR)CompletedGestational Diabetes MellitusCanada
-
University of CopenhagenThe Danish Dairy Research Foundation, Denmark; Nordea-Fonden, Denmark; LEGO Charity... and other collaboratorsActive, not recruitingObesity | Pregnancy | Gestational Age and Weight Conditions | Maternal Care for Excessive Fetal Growth | Metabolic DisordersDenmark
-
Maastricht University Medical CenterUnilever R&DCompletedObesity | Diet, Healthy | Fatty Liver, NonalcoholicNetherlands
-
Chinese University of Hong KongCompletedObesity | Central ObesityHong Kong
-
University of TorontoCompletedGestational DiabetesCanada
-
University of Massachusetts, WorcesterCompletedLow-GI Dietary Education | ADA Dietary EducationUnited States