Skip to main content
OpenTrials
Completed

NCT Number: NCT02087709

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Loss Adipokines Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio de Janeiro

Rio de Janeiro, 21941- 902, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-calorie diet

Other

Primary outcomes

  1. Weight

    Time frame: Change from baseline at 3rd month

    Change from baseline weight (Kg) at 3rd month.

Secondary outcomes

  1. Insulin resistance markers

    Time frame: Change from baseline at 3rd month

    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.

Other outcomes

  1. Adipokines

    Time frame: Change from baseline at 3rd month

    The change from baseline leptin and adiponectin at 3rd month, samples were stored at -20 degrees

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Rio de Janeiro State University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 14, 2014
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.