search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Glycemic Index Diets and Metformin hydrochloride
Sponsored by
Caio Eduardo Gonçalves Reis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Glycemic index, Caloric restriction, Energy intake, Glucose, Lipid Metabolism, Cholesterol, HDL Cholesterol, LDL Cholesterol, Obesity, Metformin

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Health Sciences, University of Brasília

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

High Glycemic Index

Low Glycemic Index

Low Glycemic Index plus Metformin

Arm Description

Hypocaloric diet with predominating high glycemic index foods

Hypocaloric diet with predominant low glycemic index foods

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
October 17, 2011
Last Updated
October 25, 2011
Sponsor
Caio Eduardo Gonçalves Reis
Collaborators
University of Brasilia, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fund to support research of the Federal District, Brazil
search

1. Study Identification

Unique Protocol Identification Number
NCT01460797
Brief Title
Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Caio Eduardo Gonçalves Reis
Collaborators
University of Brasilia, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fund to support research of the Federal District, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Glycemic index, Caloric restriction, Energy intake, Glucose, Lipid Metabolism, Cholesterol, HDL Cholesterol, LDL Cholesterol, Obesity, Metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Glycemic Index
Arm Type
Other
Arm Description
Hypocaloric diet with predominating high glycemic index foods
Arm Title
Low Glycemic Index
Arm Type
Other
Arm Description
Hypocaloric diet with predominant low glycemic index foods
Arm Title
Low Glycemic Index plus Metformin
Arm Type
Other
Arm Description
Hypocaloric diet with predominant low glycemic index foods plus Metformin (1g/d)
Intervention Type
Other
Intervention Name(s)
Glycemic Index Diets and Metformin hydrochloride
Other Intervention Name(s)
High Glycemic Index, Low Glycemic Index, High Glycemic Index plus Metformin
Intervention Description
1g of Metformin hydrochloride a day in High Glycemic Index Diet
Primary Outcome Measure Information:
Title
Glucose Metabolism
Description
2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index.
Time Frame
0 and 4 months
Secondary Outcome Measure Information:
Title
Lipid Profile
Description
Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio
Time Frame
0 and 4 months
Title
Body Composition
Description
Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.
Time Frame
0 and 4 months
Title
Clinical Assessment
Description
FSH hormone, urea, creatinine, and uric acid urinary levels
Time Frame
0 and 4 months
Title
Food Intake
Description
Energy intake, macronutrients and fiber consumption
Time Frame
0 and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa HM da Costa, Ph.D.
Organizational Affiliation
University of Brasilia
Official's Role
Study Director
Facility Information:
Facility Name
School of Health Sciences, University of Brasília
City
Brasília
State/Province
DF
ZIP/Postal Code
70910-900
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs