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

NCT ID: NCT01460797

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-10-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Glycemic Index

Hypocaloric diet with predominating high glycemic index foods

Group Type OTHER

Glycemic Index Diets and Metformin hydrochloride

Intervention Type OTHER

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

Low Glycemic Index

Hypocaloric diet with predominant low glycemic index foods

Group Type OTHER

Glycemic Index Diets and Metformin hydrochloride

Intervention Type OTHER

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

Low Glycemic Index plus Metformin

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

Group Type OTHER

Glycemic Index Diets and Metformin hydrochloride

Intervention Type OTHER

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

Interventions

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Glycemic Index Diets and Metformin hydrochloride

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

Intervention Type OTHER

Other Intervention Names

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High Glycemic Index Low Glycemic Index High Glycemic Index plus Metformin

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Brasilia

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fund to support research of the Federal District, Brazil

UNKNOWN

Sponsor Role collaborator

Caio Eduardo Gonçalves Reis

OTHER

Sponsor Role lead

Responsible Party

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Caio Eduardo Gonçalves Reis

Sub-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Teresa HM da Costa, Ph.D.

Role: STUDY_DIRECTOR

University of Brasilia

Locations

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School of Health Sciences, University of Brasília

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Glycemic index and Metformin

Identifier Type: -

Identifier Source: org_study_id