Status:
COMPLETED
Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
Lead Sponsor:
Caio Eduardo Gonçalves Reis
Collaborating Sponsors:
University of Brasilia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Obesity
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans w...
Detailed Description
All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement in body composition paramet...
Eligibility Criteria
Inclusion
- Participants were adults (18-50 y), with body mass index (BMI) between 25-35 kg/m².
- Subjects with adequate glycemic and insulinemic response after oral glucose tolerance test: Hypocaloric diet with predominating high glycemic index foods;
- Subjects with altered glycemic response presented at the 120 min point either glycemia \<140mg/dL and insulin level \>40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods;
- Subjects with impaired glucose tolerance presented at the 120 min point glycemia 140 - 199mg/dL and insulin \>40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods and metformin.
Exclusion
- Smokers
- Pregnant or lactating
- Diagnosis of any metabolic diseases
- Were under medication and therapeutic diet, except oral contraceptive for women.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01460797
Start Date
October 1 2004
End Date
October 1 2006
Last Update
October 27 2011
Active Locations (1)
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1
School of Health Sciences, University of Brasília
Brasília, Federal District, Brazil, 70910-900