Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome

Insulin Resistance Clinical Trial

Official title:

Effect of Hypocaloric Diet on Biomarkers of Metabolic Profile, Insulin Resistance and Body Composition in Women With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087709
• Other study ID #: 0535.0.000.325-08
• Secondary ID: U1111-1154-4418
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: March 13, 2014
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adipokines
• Insulin Resistance
• Metabolic Syndrome X
• Weight Loss

Intervention

Other:
• Low-calorie diet

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adipokines	The change from baseline leptin and adiponectin at 3rd month, samples were stored at -20 degrees	Change from baseline at 3rd month	Yes
Primary	Weight	Change from baseline weight (Kg) at 3rd month.	Change from baseline at 3rd month	Yes
Secondary	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.	Change from baseline at 3rd month	Yes