ObesityNCT00143078
Obesity and Weight Loss on Reproductive Function
An observational study of Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Dec 2009
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants eligible for bariatric surgery; BMI >40 or between 35 and 39.9 with a weight related health problem; Failed medical weight loss; Ages 18-40; Not using hormonal contraceptives; Females have not undergone and bilateral oophrectomy or hysterectomy; Males have not had a vasectomy
Who may be able to join
- Body mass index (BMI) of greater than 40 or a BMI between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure.
- Failed medical weight loss
- Ages of 18-40
- Not using hormonal contraception or sex steroids
- Subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy
- Subject's obesity has no medical explanation (hypothyroidism, Cushing's Syndrome, genetic)
Who cannot join
- Not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery
- Subject is pregnant or lactating
- Not willing to use barrier contraceptives or intrauterine device (IUD) to prevent pregnancy for one year following bariatric surgery
- Post-menopausal, either surgical or natural
- Subject has had a vasectomy
- Subject is a smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
The Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model
The purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Specifically, we, the researchers at Penn State University, propose to characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the short-term effects of alteration in GI hormones after bariatric surgery on reproductive function. We hypothesize that bariatric surgery radically alters GI hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. We hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men.
Read the detailed description
Obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implantation. In males, obesity may impair reproductive function by several mechanisms including: decreasing libido, causing erectile dysfunction, influencing semen composition, or sperm function. Therefore the long term goal of the current project is to understand the impact of severe obesity on reproductive function and how this is influenced by dramatic weight loss.
- Conditions
- Obesity
- Keywords
- Obesity, Reproduction, Weight Loss, Reproductive System
- Medical subject headings
- Obesity, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2009
- Study completionDec 2009
Why it stopped: Close-out of the grant - study ceased on 1/1/2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Settlement Grant
- Responsible party
- Principal investigator, Richard S. Legro, M.D., Milton S. Hershey Medical Center
- Investigators
- Richard Legro, M.D., Principal investigator, Penn State University/Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143078
- Sponsor's protocol ID
- 19366
- Status last verified
- Nov 2015
- First submitted
- 1 Sep 2005
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model
- ClinicalTrials.gov ID
- NCT00143078
- Acronym / sponsor ID
- 19366
- Conditions
- Obesity
- Keywords
- Obesity, Reproduction, Weight Loss, Reproductive System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Close-out of the grant - study ceased on 1/1/2010
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Tobacco Settlement Grant
- Study start
- Jun 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Sep 2005 (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 examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Specifically, we, the researchers at Penn State University, propose to characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the short-term effects of alteration in GI hormones after bariatric surgery on reproductive function. We hypothesize that bariatric surgery radically alters GI hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. We hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men.
Detailed description
Obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implantation. In males, obesity may impair reproductive function by several mechanisms including: decreasing libido, causing erectile dysfunction, influencing semen composition, or sperm function. Therefore the long term goal of the current project is to understand the impact of severe obesity on reproductive function and how this is influenced by dramatic weight loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants eligible for bariatric surgery; BMI >40 or between 35 and 39.9 with a weight related health problem; Failed medical weight loss; Ages 18-40; Not using hormonal contraceptives; Females have not undergone and bilateral oophrectomy or hysterectomy; Males have not had a vasectomy
Key inclusion criteria (6 listed)
- Body mass index (BMI) of greater than 40 or a BMI between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure.
- Failed medical weight loss
- Ages of 18-40
- Not using hormonal contraception or sex steroids
- Subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy
Key exclusion criteria (6 listed)
- Not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery
- Subject is pregnant or lactating
- Not willing to use barrier contraceptives or intrauterine device (IUD) to prevent pregnancy for one year following bariatric surgery
- Post-menopausal, either surgical or natural
- Subject has had a vasectomy
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
Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Close-out of the grant - study ceased on 1/1/2010). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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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.
Richard Legro, M.D. principal investigator
Penn State University/Milton S. Hershey Medical 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 Obesity, run by Milton S. Hershey Medical 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Nov 2015. 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 was stopped early (reason given: Close-out of the grant - study ceased on 1/1/2010). Results are not available in the source record.
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.
What does the primary outcome measure?
Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2015.