NCT00667030

Brief Summary

Over half of adults in this country are overweight. This increases risk for heart and blood pressure problems, cancer, stroke and arthritis. While it is difficult to lose large amounts of weight and keep it off, even small amounts of weight loss can improve health. Furthermore, fat is increasingly recognized as a source of substances that increase inflammation. It may be that some of the adverse consequences of being overweight are due to increased inflammation. We are asking you to volunteer for a research study in which you may lose a moderate amount of weight and increase your activity. It is important that you read and understand the information on this form. The purposes of these studies are to determine the influence(s) of age and body composition on the production of inflammatory chemicals by fat (adipose tissue), the mechanisms controlling this, and if a weight loss and aerobic exercise intervention results in a decrease in inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

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

July 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

13.2 years

First QC Date

April 23, 2008

Last Update Submit

February 18, 2026

Conditions

Keywords

InflammationAgingMetabolismExercise

Outcome Measures

Primary Outcomes (1)

  • Regional Adipokine Release

    6 month

Secondary Outcomes (1)

  • Cardiovascular Fitness Body Composition Glucose Tolerance/Insulin Sensitivity

    6 month

Study Arms (1)

Lifestyle Modification

EXPERIMENTAL

Combined hypocaloric diet and aerobic exercise training

Behavioral: Weight loss and aerobic exercise training

Interventions

Weight loss and aerobic exercise training

Lifestyle Modification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 20-40 kg/m2
  • Waist 80-120cm (men), 70-110cm (women)
  • Stable Medical Regimen \> or = 30 days
  • All women over the age of 50 must be postmenopausal for at least 1 year, have serum FSH \>30 mIU/ml, and agree to remain off hormone replacement therapy for the duration of the study

You may not qualify if:

  • Pregnancy or Nursing Mothers
  • Cigarette Smoking
  • Diabetes on Medication or Fasting Glucose \>126 mg/dl
  • Poorly controlled hypertension requiring \>3 drugs or beta blockers
  • Hyperlipidemia with TG\>400mg/dl, LDL\>190mg/dl or on Lipitor or Crestor
  • Other medications affecting glucose, lipid or cytokine levels
  • Thyroid Disease
  • Weight gain/loss \>5kg in preceding 3 months
  • Alcohol \>3oz/day
  • Caffeine \>120 oz/day
  • Chronic liver, renal or hematological disease
  • Lung disease requiring oxygen
  • Active cancer on radiation or chemotherapy treatment
  • HIV (+) or other disease prone to malnutrition
  • Sickle cell anemia
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland; Baltimore VA Medical Center

Baltimore, Maryland, 21044, United States

Location

MeSH Terms

Conditions

InflammationMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jacob B Blumenthal, MD

    Baltimore VA Medical Center, University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

July 1, 2005

Primary Completion

September 13, 2018

Study Completion

September 13, 2018

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations