Back to resultsEffect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome
Primary Purpose
Weight Loss, Insulin Resistance, Adipokines
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low-calorie diet
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002)
Exclusion Criteria:
- Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.
Sites / Locations
- Federal University of Rio de Janeiro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-calorie diet
Arm Description
The subjects were prescribed a daily energy intake 500 kcal lower than the estimated energy requirement.
Outcomes
Primary Outcome Measures
Weight
Change from baseline weight (Kg) at 3rd month.
Secondary Outcome Measures
Insulin resistance markers
Change from baseline fasting glucose and insulin, homeostasis model assessment-insulin resistance and quantitative insulin sensitivity check index at 3rd month, samples were stored at -20 degrees.
Full Information
NCT ID
NCT02087709
First Posted
March 12, 2014
Last Updated
March 13, 2014
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State University, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
1. Study Identification
Unique Protocol Identification Number
NCT02087709
Brief Title
Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome
Official Title
Effect of Hypocaloric Diet on Biomarkers of Metabolic Profile, Insulin Resistance and Body Composition in Women With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State University, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers associated with insulin resistance, metabolic profile and body composition in women with Metabolic Syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Insulin Resistance, Adipokines
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-calorie diet
Arm Type
Experimental
Arm Description
The subjects were prescribed a daily energy intake 500 kcal lower than the estimated energy requirement.
Intervention Type
Other
Intervention Name(s)
Low-calorie diet
Primary Outcome Measure Information:
Title
Weight
Description
Change from baseline weight (Kg) at 3rd month.
Time Frame
Change from baseline at 3rd month
Secondary Outcome Measure Information:
Title
Insulin resistance markers
Description
Change from baseline fasting glucose and insulin, homeostasis model assessment-insulin resistance and quantitative insulin sensitivity check index at 3rd month, samples were stored at -20 degrees.
Time Frame
Change from baseline at 3rd month
Other Pre-specified Outcome Measures:
Title
Adipokines
Description
The change from baseline leptin and adiponectin at 3rd month, samples were stored at -20 degrees
Time Frame
Change from baseline at 3rd month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002)
Exclusion Criteria:
Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941- 902
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome
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