ObesityMIGNCT01693406
Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers
An observational study of Obesity and Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Childhood obesity is a critical global public health concern. Breastfeeding is the ideal choice for infant nutrition. However, rapid and excess weight gain during infancy predicts later, even among breastfed infants. This risk is higher if mothers are obese and/or diabetic. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Gestational Diabetes
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Sep 2020
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: We will recruit pregnant women in the Denver Colorado area who plan to deliver their infant at the University of Colorado Hospital, and plan to exclusively breastfeed their infant for at least 5 months.
Who may be able to join
- Between 28-40 weeks gestation
- Plan to Exclusively Breastfeed for at least 5 months
- Between 20 - 35 years old
- Carrying a singleton pregnancy
- Parity less than or equal to 5
- Pre-pregnancy BMI between 18.5 and 39.9
Who cannot join
- No known infant anomalies or birth defects
- Maternal Type 1 Diabetes
- Maternal major medical condition (ie: Kidney Disease or Pre-eclampsia)
- Delivery of the infant before 35 weeks gestation
- Smoking During pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes
Childhood obesity is a critical global public health concern. Breastfeeding is the ideal choice for infant nutrition. However, rapid and excess weight gain during infancy predicts later, even among breastfed infants. This risk is higher if mothers are obese and/or diabetic. Composition of bioactive components of breast milk may differ based between mothers who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are associated with overall increases in inflammation and oxidative stress, but how breast milk composition is affected remains unknown. The investigators overarching goal is to determine how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how differences in composition may impact infant growth and fat development. The investigators are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and 20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The investigators will track infant weight and fat gain and monitor maternal glucose control. The investigators will also collect breast milk samples over the first 4 months and measure concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and nutrient composition in milk. The investigators predict that concentrations of growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers' breast milk. The investigators expect these differences will be most pronounced in the first 2 weeks after birth. The investigators also predict that breast milk concentrations of these biomarkers will be associated with infant fat gain. What the investigators find will help understand how early infant nutrition and growth may affect that child's later risk of obesity.
- Conditions
- Obesity, Type 2 Diabetes, Gestational Diabetes
- Keywords
- human milk, infant growth, obesity, diabetes, breastfeeding
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes, Gestational, Diabetes Mellitus, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2. | |
| Overweight/Obese | Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2. | |
| Gestational Diabetes | Women who develop gestational diabetes and return to normal glucose control after delivery. | |
| Type 2 Diabetes | Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI > 25 kg/m2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infant percent body fat from birth to 4 months
Body composition is measured by skin folds and air displacement plethysmography (PeaPod)
Measured: Birth, 2 weeks, 1, 2, 3, and 4 months
Secondary outcomes (3)
Change in Human Milk Hormone Composition
The investigators will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points
Measured: 2 weeks, 1, 2, 3, and 4 months
Change in Human Milk cytokine content
The investigators will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points
Measured: 2 weeks, 1, 2, 3, and 4 months
Change in Antioxidant capacity of human milk
The investigators will analyze: TBARS, 8-OH-dG, HNE, and F2-isoprostane concentrations and total antioxidant capacity in human milk samples collected at these time points.
Measured: 2 weeks, 1, 2, 3, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund, American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Nancy F Krebs, MD, MS, Principal investigator, University of Colorado, DenverLinda A Barbour, MD, MSPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693406
- Sponsor's protocol ID
- 12-0629
- Acronym
- MIG
- Status last verified
- Nov 2020
- First submitted
- 21 Sep 2012
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26.
PubMed 37506974Lemas DJ, Young BE, Baker PR 2nd, Tomczik AC, Soderborg TK, Hernandez TL, de la Houssaye BA, Robertson CE, Rudolph MC, Ir D, Patinkin ZW, Krebs NF, Santorico SA, Weir T, Barbour LA, Frank DN, Friedman JE. Alterations in human milk leptin and insulin are associated with early changes in the infant intestinal microbiome. Am J Clin Nutr. 2016 May;103(5):1291-300. doi: 10.3945/ajcn.115.126375.
PubMed 27140533
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes
- ClinicalTrials.gov ID
- NCT01693406
- Acronym / sponsor ID
- MIG / 12-0629
- Conditions
- Obesity, Type 2 Diabetes, Gestational Diabetes
- Keywords
- human milk, infant growth, obesity, diabetes, breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund, American Diabetes Association
- Study start
- Aug 2012
- Primary completion
- Aug 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 26 Sep 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.
Childhood obesity is a critical global public health concern. Breastfeeding is the ideal choice for infant nutrition. However, rapid and excess weight gain during infancy predicts later, even among breastfed infants. This risk is higher if mothers are obese and/or diabetic. Composition of bioactive components of breast milk may differ based between mothers who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are associated with overall increases in inflammation and oxidative stress, but how breast milk composition is affected remains unknown. The investigators overarching goal is to determine how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how differences in composition may impact infant growth and fat development. The investigators are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and 20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The investigators will track infant weight and fat gain and monitor maternal glucose control. The investigators will also collect breast milk samples over the first 4 months and measure concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and nutrient composition in milk. The investigators predict that concentrations of growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers' breast milk. The investigators expect these differences will be most pronounced in the first 2 weeks after birth. The investigators also predict that breast milk concentrations of these biomarkers will be associated with infant fat gain. What the investigators find will help understand how early infant nutrition and growth may affect that child's later risk of obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | – | –Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2. |
| Overweight/Obese | – | –Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2. |
| Gestational Diabetes | – | –Women who develop gestational diabetes and return to normal glucose control after delivery. |
| Type 2 Diabetes | – | –Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI > 25 kg/m2. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We will recruit pregnant women in the Denver Colorado area who plan to deliver their infant at the University of Colorado Hospital, and plan to exclusively breastfeed their infant for at least 5 months.
Key inclusion criteria (6 listed)
- Between 28-40 weeks gestation
- Plan to Exclusively Breastfeed for at least 5 months
- Between 20 - 35 years old
- Carrying a singleton pregnancy
- Parity less than or equal to 5
Key exclusion criteria (5 listed)
- No known infant anomalies or birth defects
- Maternal Type 1 Diabetes
- Maternal major medical condition (ie: Kidney Disease or Pre-eclampsia)
- Delivery of the infant before 35 weeks gestation
- Smoking During pregnancy
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
Change in infant percent body fat from birth to 4 months
Time frame: Birth, 2 weeks, 1, 2, 3, and 4 months
Body composition is measured by skin folds and air displacement plethysmography (PeaPod)
3 secondary outcomes
Change in Human Milk Hormone Composition
Time frame: 2 weeks, 1, 2, 3, and 4 months
Change in Human Milk cytokine content
Time frame: 2 weeks, 1, 2, 3, and 4 months
Change in Antioxidant capacity of human milk
Time frame: 2 weeks, 1, 2, 3, and 4 months
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 20 Nov 2020.
- Derived from this study: PubMed 37506974Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26.
- Derived from this study: PubMed 27140533Lemas DJ, Young BE, Baker PR 2nd, Tomczik AC, Soderborg TK, Hernandez TL, de la Houssaye BA, Robertson CE, Rudolph MC, Ir D, Patinkin ZW, Krebs NF, Santorico SA, Weir T, Barbour LA, Frank DN, Friedman JE. Alterations in human milk leptin and insulin are associated with early changes in the infant intestinal microbiome. Am J Clin Nutr. 2016 May;103(5):1291-300. doi: 10.3945/ajcn.115.126375.
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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.
Nancy F Krebs, MD, MS principal investigator
University of Colorado, Denver
Linda A Barbour, MD, MSPH principal investigator
University of Colorado, Denver
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 and Type 2 Diabetes, run by University of Colorado, Denver 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 5 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 20 Nov 2020. 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?
Change in infant percent body fat from birth to 4 months (time frame: Birth, 2 weeks, 1, 2, 3, and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693406, which also lists 2 linked publications.
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 20 Nov 2020.