Trial record 1 of 503 for:
obesity, overweight, and body composition
Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
This study has been completed.
Sponsor:
Caio Eduardo Gonçalves Reis
Collaborators:
University of Brasilia
National Council of Technological and Scientific Development, Brazil
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
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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:
|
|
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:
|
|
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:
|
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
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
National Council of Technological and Scientific Development, Brazil
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 May 19, 2013