NCT02087709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

March 12, 2014

Last Update Submit

March 13, 2014

Conditions

Weight LossInsulin ResistanceAdipokines

Outcome Measures

Primary Outcomes (1)

  • Weight

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

    Change from baseline at 3rd month

Secondary Outcomes (1)

  • Insulin resistance markers

    Change from baseline at 3rd month

Other Outcomes (1)

  • Adipokines

    Change from baseline at 3rd month

Study Arms (1)

Low-calorie diet

EXPERIMENTAL

The subjects were prescribed a daily energy intake 500 kcal lower than the estimated energy requirement.

Other: Low-calorie diet

Interventions

Low-calorie dietOTHER
Low-calorie diet

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002)

You may not qualify if:

  • Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941- 902, Brazil

Location

MeSH Terms

Conditions

Weight LossInsulin Resistance

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

May 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

BR(1)