NCT00588978

Brief Summary

The purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.

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 cardiovascular-diseases

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable cardiovascular-diseases

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

August 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

December 27, 2007

Last Update Submit

April 16, 2020

Conditions

Cardiovascular Diseases

Keywords

c-reactive proteinobesitywomen's cardiovascular health

Outcome Measures

Primary Outcomes (1)

  • c-reactive protein

    baseline, every 1-2 weeks during intervention , then end-of-study

Secondary Outcomes (1)

  • HOMA (measure of insulin resistance) and sex steroids

    baseline, every 1-2 weeks during intervention, then end-of-study

Study Arms (3)

1

ACTIVE COMPARATOR

Diet alone

Behavioral: diet and/or exercise

2

ACTIVE COMPARATOR

Exercise alone

Behavioral: diet and/or exercise

3

ACTIVE COMPARATOR

Diet and exercise (combined)

Behavioral: diet and/or exercise

Interventions

diet and/or exerciseBEHAVIORAL

Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

123

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obese postmenopausal women
  • able to exercise
  • non-smokers

You may not qualify if:

  • cardiovascular disease
  • medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
  • known diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara I Gulanski, MD, MPH

    Yale Univeristy School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 9, 2008

Study Start

August 1, 2003

Primary Completion

February 1, 2007

Study Completion

December 1, 2008

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

US(1)