MenopauseNCT00412269
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
An observational study of Menopause, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women. Read more about this study
- Who is it for?
- Ages 47 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pennington Biomedical Research Center is located in Baton Rouge, Louisiana, adjacent to the medical services district of the Regional Medical Center. The city of Baton Rouge is the home of state government, the 27,000-student Louisiana State University, the 9,000-student Southern University and a large petrochemical industry. Lacking the traditional active urban "downtown", the region is characterized by the suburban pattern of single family subdivisions and small apartment complexes. The population within a 7 parish (i.e. county) area is 635,202. The population of East Baton Rouge Parish is 380,105 with an ethnic distribution of 62% Caucasian, 35% African-American, 1% Asian, and <1% Native American and Hispanic. There are 34,885 people over age 65 and 251,586 between ages 16-65 yr.
Who may be able to join
- Age 47-52 yr, at time of enrollment
- Body Mass Index 25-40
- Normal oral glucose tolerance test by National Diabetes Data Group criteria
- Premenopausal, defined by FSH levels <30mIU/ml and at least 5 menstrual periods in the last 6 months
- Able to confirm ethnic heritage of past 2 generations in family
Who cannot join
- hypertension or hypercholesterolemia requiring medication
- regular use of medications that influence glucose tolerance
- use of oral contraceptives within the past 6 months
- history of myocardial infarction or significant coronary vascular disease or stroke
- history of endocrine, kidney, or liver disease or malignancy
- any psychopathology, including eating disorders, substance abuse, and major depression
- unable to complete longitudinal study commitment, including anticipating moving out of the area within the next 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.
Read the detailed description
The effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. In contrast, there are few data available on menopause in African-American women. Since menopause is associated with potentially preventable health risks in women, this proposal is aimed at characterizing the perimenopausal period in terms of body fat, energy balance, and insulin action in both caucasian and African-American women.
The study will address 4 general hypotheses:
- Menopause increases both total and visceral abdominal fat
- Changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake
- Menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life
- African-American women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.
- Conditions
- Menopause
- Keywords
- Insulin Sensitivity, Total abdominal fat, Visceral abdominal fat, Reproductive Hormones, Menopause, Diabetes, Fat Distribution, Sex Hormones
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startFeb 1998
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Donna H. Ryan, MD, Pennington Biomedical Research Center
- Investigators
- Steven R Smith, M. D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412269
- Sponsor's protocol ID
- PBRC 97022
- Status last verified
- Jan 2016
- First submitted
- 14 Dec 2006
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lovejoy JC, Champagne CM, de Jonge L, Xie H, Smith SR. Increased visceral fat and decreased energy expenditure during the menopausal transition. Int J Obes (Lond). 2008 Jun;32(6):949-58. doi: 10.1038/ijo.2008.25. Epub 2008 Mar 11.
PubMed 18332882
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
- ClinicalTrials.gov ID
- NCT00412269
- Acronym / sponsor ID
- PBRC 97022
- Conditions
- Menopause
- Keywords
- Insulin Sensitivity, Total abdominal fat, Visceral abdominal fat, Reproductive Hormones, Menopause, Diabetes, Fat Distribution, Sex Hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 1998
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 18 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.
Detailed description
The effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. In contrast, there are few data available on menopause in African-American women. Since menopause is associated with potentially preventable health risks in women, this proposal is aimed at characterizing the perimenopausal period in terms of body fat, energy balance, and insulin action in both caucasian and African-American women.
The study will address 4 general hypotheses:
- Menopause increases both total and visceral abdominal fat
- Changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake
- Menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life
- African-American women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 47 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pennington Biomedical Research Center is located in Baton Rouge, Louisiana, adjacent to the medical services district of the Regional Medical Center. The city of Baton Rouge is the home of state government, the 27,000-student Louisiana State University, the 9,000-student Southern University and a large petrochemical industry. Lacking the traditional active urban "downtown", the region is characterized by the suburban pattern of single family subdivisions and small apartment complexes. The population within a 7 parish (i.e. county) area is 635,202. The population of East Baton Rouge Parish is 380,105 with an ethnic distribution of 62% Caucasian, 35% African-American, 1% Asian, and <1% Native American and Hispanic. There are 34,885 people over age 65 and 251,586 between ages 16-65 yr.
Key inclusion criteria (5 listed)
- Age 47-52 yr, at time of enrollment
- Body Mass Index 25-40
- Normal oral glucose tolerance test by National Diabetes Data Group criteria
- Premenopausal, defined by FSH levels <30mIU/ml and at least 5 menstrual periods in the last 6 months
- Able to confirm ethnic heritage of past 2 generations in family
Key exclusion criteria (7 listed)
- hypertension or hypercholesterolemia requiring medication
- regular use of medications that influence glucose tolerance
- use of oral contraceptives within the past 6 months
- history of myocardial infarction or significant coronary vascular disease or stroke
- history of endocrine, kidney, or liver disease or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Derived from this study: PubMed 18332882Lovejoy JC, Champagne CM, de Jonge L, Xie H, Smith SR. Increased visceral fat and decreased energy expenditure during the menopausal transition. Int J Obes (Lond). 2008 Jun;32(6):949-58. doi: 10.1038/ijo.2008.25. Epub 2008 Mar 11.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Smith, M. D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.