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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 Brasília

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 Profile

Body 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 Brasília, Brasília, DF 70910-900, Brazil
Additional Information

Starting date: October 2004
Last updated: October 25, 2011

Page last updated: August 23, 2015

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