Maternal Obesity SyndromeNCT01514539
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
A study testing cross-sectional in people with Maternal Obesity Syndrome, run by University of Wyoming at 1 site in United States.
Trial summary
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Obesity Syndrome
- What is being tested?
- cross-sectional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2014
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month.
- The study is open to women who are breastfeeding or formula feeding.
Who cannot join
- Smoker,
- had twins or triples,
- had any major complication of pregnancy(example,
- gestational diabetes);
- have kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. This also includes high blood pressure;
- use prescription or over-the-counter medicine or herbal drinks or pills.
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- History of depression, anxiety, disordered eating, other psychological problems, alcoholism or other substance abuse.
- Severely claustrophobic.
- Having a strong fear of needles and/or do not feel you can have blood drawn every 30 minutes from a plastic catheter.
- Are not able to or willing to fully participate in the study, and are pregnant, anemic or have a thyroid problem.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutritional and Exercise Lab University of Wyoming
Laramie, Wyoming, 82071
About this study
Official title: Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective.
Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/
Read the detailed description
Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.
This study evaluated whether fasting or postprandial ghrelin or PYY is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity.
Eligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth.
- Conditions
- Maternal Obesity Syndrome
- Being tested
- cross-sectional
- Keywords
- Human milk, Ghrelin,PYY and maternal obesity.
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectionalOther
Monitoring two recently discovered appetite hormones called "ghrelin" and "neuropeptide YY (PYY)." This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity.
| Study group | Role | What they receive |
|---|---|---|
| Four weeks Postpartum Lactating | Other | women between 18 and 45 who delivered their first child 4 weeks prior and who were currently lactating and planning to lactate for one year postpartum. Receives: Other: cross-sectional |
| Control Never Pregnant | Other | women between 18 and 45 who have never been pregnant Receives: Other: cross-sectional |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
Biomedical Research Study that will provide information on reducing maternal obesity.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startAug 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Obesity SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enette Larson-Meyer, University of Wyoming
- Investigators
- Dawine E. Larson-Meyer, Phd, RD, Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514539
- Sponsor's protocol ID
- P20RR016474
- Status last verified
- Jan 2015
- First submitted
- 9 Jan 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk
- ClinicalTrials.gov ID
- NCT01514539
- Acronym / sponsor ID
- P20RR016474
- Conditions
- Maternal Obesity Syndrome
- Keywords
- Human milk, Ghrelin,PYY and maternal obesity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Jan 2012 (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.
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective.
Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/
Detailed description
Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.
This study evaluated whether fasting or postprandial ghrelin or PYY is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity.
Eligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four weeks Postpartum Lactating | Other | Other: cross-sectionalwomen between 18 and 45 who delivered their first child 4 weeks prior and who were currently lactating and planning to lactate for one year postpartum. |
| Control Never Pregnant | Other | Other: cross-sectionalwomen between 18 and 45 who have never been pregnant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month.
- The study is open to women who are breastfeeding or formula feeding.
Key exclusion criteria (10 listed)
- Smoker,
- had twins or triples,
- had any major complication of pregnancy(example,
- gestational diabetes);
- have kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. This also includes high blood pressure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-sectionalMonitoring two recently discovered appetite hormones called "ghrelin" and "neuropeptide YY (PYY)." This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity. | Other | Control Never Pregnant, Four weeks Postpartum Lactating |
Primary outcome
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
Time frame: 5 years
Biomedical Research Study that will provide information on reducing maternal obesity.
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 9 Jan 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.
Dawine E. Larson-Meyer, Phd, RD principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cross-sectional in people with Maternal Obesity Syndrome, run by University of Wyoming 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 2 inclusion and 10 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 9 Jan 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 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.
What does the primary outcome measure?
"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk" (time frame: 5 years). 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 9 Jan 2015.