NCT00416156

Brief Summary

To investigate whether weight reduction by life style modification for 12 weeks will improve circulating inflammatory markers, adipocytokines as well as gene expression of proinflammatory protein obtained from circulating monocytes from obese individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable obesity

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, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
Last Updated

December 27, 2006

Status Verified

December 1, 2006

First QC Date

December 25, 2006

Last Update Submit

December 26, 2006

Conditions

ObesityInflammation

Keywords

ObesityInflammation

Outcome Measures

Primary Outcomes (1)

  • Inflammatory responses after weight reduction

Secondary Outcomes (4)

  • BMI

  • Circulating inflammatory markers

  • Adipocytokines

  • Gene Expression from mononuclear cells

Interventions

Lifestyle modificationBEHAVIORAL

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nondiabetes obese individuals with BMI greater than 27 kgs/m2

You may not qualify if:

  • Diabetes
  • Abnormal hepatic, renal and cardiac function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

ObesityInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Wayne H Sheu, MD, PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 25, 2006

First Posted

December 27, 2006

Study Start

May 1, 2005

Study Completion

November 1, 2005

Last Updated

December 27, 2006

Record last verified: 2006-12

Locations

TW(1)