Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers (MIG)
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|ClinicalTrials.gov Identifier: NCT01693406|
Recruitment Status : Recruiting
First Posted : September 26, 2012
Last Update Posted : December 6, 2017
|Condition or disease|
|Obesity Type 2 Diabetes Gestational Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||September 2020|
Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.
Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2.
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.
- 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)
- Change in Human Milk Hormone Composition [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ]The investigators will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points
- Change in Human Milk cytokine content [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ]The investigators will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points
- Change in Antioxidant capacity of human milk [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ]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.
- Change in Human Milk Nutrient Composition [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ]The investigators will analyze: glucose, percent fat, protein and caloric content of human milk samples collected at these time points.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693406
|Contact: Nichole Hirsch, MS||(303) 724-8966||NICOLE.HIRSCH@UCDENVER.EDU|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Nichole Hirsch, MS 303-724-8966 NICOLE.HIRSCH@UCDENVER.EDU|
|Principal Investigator: Nancy F Krebs, MD, MS|
|Principal Investigator: Linda A Barbour, MD, MSPH|
|Principal Investigator:||Nancy F Krebs, MD, MS||University of Colorado, Denver|
|Principal Investigator:||Linda A Barbour, MD, MSPH||University of Colorado, Denver|