NCT01514539

Brief 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. 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/

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

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

August 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

4.7 years

First QC Date

January 9, 2012

Last Update Submit

January 7, 2015

Conditions

Maternal Obesity Syndrome

Keywords

Human milk, Ghrelin,PYY and maternal obesity.

Outcome Measures

Primary Outcomes (1)

  • "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.

    5 years

Study Arms (2)

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.

Other: cross-sectional

Control Never Pregnant

OTHER

women between 18 and 45 who have never been pregnant

Other: cross-sectional

Interventions

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.

Control Never PregnantFour weeks Postpartum Lactating

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutritional and Exercise Lab University of Wyoming

Laramie, Wyoming, 82071, United States

Location

MeSH Terms

Conditions

Pregnancy in Obesity

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dawine E. Larson-Meyer, Phd, RD

    University of Wyoming

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, RD, FACSM

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 23, 2012

Study Start

August 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

US(1)