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
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|