Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects

Sponsor

Caio Eduardo Gonçalves Reis (Other)

Overall Status

Completed

CT.gov ID

NCT01460797

Collaborator

University of Brasilia (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Fund to support research of the Federal District, Brazil (Other)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Glycemic Index Diets and Metformin hydrochloride	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: High Glycemic Index Hypocaloric diet with predominating high glycemic index foods	Other: Glycemic Index Diets and Metformin hydrochloride 1g of Metformin hydrochloride a day in High Glycemic Index Diet Other Names: High Glycemic Index Low Glycemic Index High Glycemic Index plus Metformin
Other: Low Glycemic Index Hypocaloric diet with predominant low glycemic index foods	Other: Glycemic Index Diets and Metformin hydrochloride 1g of Metformin hydrochloride a day in High Glycemic Index Diet Other Names: High Glycemic Index Low Glycemic Index High Glycemic Index plus Metformin
Other: Low Glycemic Index plus Metformin Hypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d)	Other: Glycemic Index Diets and Metformin hydrochloride 1g of Metformin hydrochloride a day in High Glycemic Index Diet Other Names: High Glycemic Index Low Glycemic Index High Glycemic Index plus Metformin

Arm

Intervention/Treatment

Other: High Glycemic Index

Hypocaloric diet with predominating high glycemic index foods

Other: Glycemic Index Diets and Metformin hydrochloride

1g of Metformin hydrochloride a day in High Glycemic Index Diet

Other Names:

High Glycemic Index

Low Glycemic Index

High Glycemic Index plus Metformin

Other: Low Glycemic Index

Hypocaloric diet with predominant low glycemic index foods

Other: Glycemic Index Diets and Metformin hydrochloride

1g of Metformin hydrochloride a day in High Glycemic Index Diet

Other Names:

High Glycemic Index

Low Glycemic Index

High Glycemic Index plus Metformin

Other: Low Glycemic Index plus Metformin

Hypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d)

Other: Glycemic Index Diets and Metformin hydrochloride

1g of Metformin hydrochloride a day in High Glycemic Index Diet

Other Names:

High Glycemic Index

Low Glycemic Index

High Glycemic Index plus Metformin

Outcome Measures

Primary Outcome Measures

Glucose Metabolism [0 and 4 months]
2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index.

Secondary Outcome Measures

Lipid Profile [0 and 4 months]
Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio
Body Composition [0 and 4 months]
Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.
Clinical Assessment [0 and 4 months]
FSH hormone, urea, creatinine, and uric acid urinary levels
Food Intake [0 and 4 months]
Energy intake, macronutrients and fiber consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.