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

This study has been completed.
Sponsor:
Collaborators:
University of Brasilia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fund to support research of the Federal District, Brazil
Information provided by (Responsible Party):
Caio Eduardo Gonçalves Reis, University of Brasilia
ClinicalTrials.gov Identifier:
NCT01460797
First received: October 17, 2011
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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 Intervention
Obesity
Other: Glycemic Index Diets and Metformin hydrochloride

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • Glucose Metabolism [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
    Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio

  • Body Composition [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
    Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.

  • Clinical Assessment [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
    FSH hormone, urea, creatinine, and uric acid urinary levels

  • Food Intake [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]
    Energy intake, macronutrients and fiber consumption


Enrollment: 41
Study Start Date: October 2004
Study Completion Date: October 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460797

Locations
Brazil
School of Health Sciences, University of Brasília
Brasília, DF, Brazil, 70910-900
Sponsors and Collaborators
Caio Eduardo Gonçalves Reis
University of Brasilia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fund to support research of the Federal District, Brazil
Investigators
Study Director: Teresa HM da Costa, Ph.D. University of Brasília
  More Information

No publications provided

Responsible Party: Caio Eduardo Gonçalves Reis, Sub-Investigator, University of Brasilia
ClinicalTrials.gov Identifier: NCT01460797     History of Changes
Other Study ID Numbers: Glycemic index and Metformin
Study First Received: October 17, 2011
Last Updated: October 25, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Brasilia:
Glycemic index
Caloric restriction
Energy intake
Glucose
Lipid Metabolism
Cholesterol
HDL Cholesterol
LDL Cholesterol
Obesity
Metformin

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014