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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Other: Glycemic Index Diets and Metformin hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Glycemic Index<br>Hypocaloric diet with predominating high glycemic index foods | Other: Glycemic Index Diets and Metformin hydrochloride<br>* 1g of Metformin hydrochloride a day in High Glycemic Index Diet<br>* Other names: High Glycemic Index plus Metformin;|
| Other: Low Glycemic Index<br>Hypocaloric diet with predominant low glycemic index foods | Other: Glycemic Index Diets and Metformin hydrochloride<br>* 1g of Metformin hydrochloride a day in High Glycemic Index Diet<br>* Other names: High Glycemic Index plus Metformin;|
| Other: Low Glycemic Index plus Metformin<br>Hypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d) | Other: Glycemic Index Diets and Metformin hydrochloride<br>* 1g of Metformin hydrochloride a day in High Glycemic Index Diet<br>* Other names: High Glycemic Index plus Metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Metabolism | 2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index. | 0 and 4 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic index, Caloric restriction, Energy intake, Glucose, Lipid Metabolism, Cholesterol, HDL Cholesterol, LDL Cholesterol, Obesity, Metformin