Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
Information source: University of Brasilia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Glycemic Index Diets and Metformin hydrochloride (Other)
Phase: N/A
Status: Completed
Sponsored by: Caio Eduardo Gonçalves Reis Official(s) and/or principal investigator(s): Teresa HM da Costa, Ph.D., Study Director, Affiliation: University of BrasÃlia
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 was not investigated yet. We hypothesized that the low-GI diet in
combination with metformin would elicit greater improvements on glucose metabolism, lipid
profile and body composition on overweight or obese type 1 subjects. This study aims to
evaluate the metabolic effects of the adoption of dietary advice to follow caloric
restriction high/low GI diets, and low-GI diet associated with metformin on glucose
metabolism, lipid profile and body composition on overweight or obese type 1 subjects.
Clinical Details
Official title: Effects of a Caloric Restriction High/Low-glycemic Index Diets and in Combination With Metformin on Glucose Metabolism, Lipid Profile and Body Composition in Overweight/Obese Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Glucose Metabolism
Secondary outcome: Lipid ProfileBody Composition Clinical Assessment Food Intake
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 parameters. In addition, the Low-GI group achieved better results in
metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids
(Chol, TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on
metabolic parameters in overweight or obese type 1 subjects.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Smokers
- Pregnant or lactating
- Diagnosis of any metabolic diseases
- Were under medication and therapeutic diet, except oral contraceptive for women.
Locations and Contacts
School of Health Sciences, University of BrasÃlia, BrasÃlia, DF 70910-900, Brazil
Additional Information
Starting date: October 2004
Last updated: October 25, 2011
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