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OpenTrials
Completed

NCT Number: NCT01460797

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Sciences, University of Brasília

Brasília, Federal District, 70910-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glycemic Index Diets and Metformin hydrochloride

Other

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

Other names: High Glycemic Index, Low Glycemic Index, High Glycemic Index plus Metformin

Primary outcomes

  1. Glucose Metabolism

    Time frame: 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 outcomes

  1. Lipid Profile

    Time frame: 0 and 4 months

    Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio

  2. Body Composition

    Time frame: 0 and 4 months

    Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.

  3. Clinical Assessment

    Time frame: 0 and 4 months

    FSH hormone, urea, creatinine, and uric acid urinary levels

  4. Food Intake

    Time frame: 0 and 4 months

    Energy intake, macronutrients and fiber consumption

Sponsors and collaborators

Lead sponsor

Caio Eduardo Gonçalves Reis

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Oct 27, 2011
Registry last updated
Oct 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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