Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT03524469
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2018-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Studying Infant Nutrition and Blood Sugar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'maternal blood, stool and breast milk infant urine, stool and dried blood spot card'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean infant postprandial C peptide to creatinine ratio', 'timeFrame': '2 weeks', 'description': 'Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.'}], 'secondaryOutcomes': [{'measure': 'mean infant insulinogenic index', 'timeFrame': '5 months', 'description': 'The insulinogenic index will be measures in infant blood at 0 and 30 minutes post glucose administration. The index is the change in insulin over the change in glucose.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The inclusion criteria were selected to include only healthy infants of uncomplicated pregnancy (with the exception of gestational diabetes) and normal birth weight. The criteria for insulin resistance were strategically defined to capture the insulin-resistant population which represents a large proportion of the population that are at risk for diabetes but have not yet developed the disease. Insulin therapy is an exclusion criteria because it passes through the breast milk and we are unable to distinguish endogenous maternal insulin from exogenous therapeutic insulin in breast milk samples. These criteria will minimize the risks and increase the safety of subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers ≥ 19 years of age\n* Mothers intending to Exclusively Breastfeed for at least 5months\n* Mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum\n* Trial of labor (no scheduled C-sections)\n* Singleton birth\n* Healthy Infants\n* "Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test.\n* "Insulin Resistance" will be defined as meeting any of the following:\n\n * pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test\n * pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth.\n * pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy\n * pre-pregnant BMI ≥ 30, and unmediated.\n\nExclusion Criteria:\n\n* Scheduled C-sections or emergency C-sections with no labor (natural or induced)\n* Maternal insulin therapy after birth\n* Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.\n* Delivery before 37 weeks\n* Infant birth weight \\<2500g\n* Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns\n* Infant supplementation with infant formula (glucose gel or donor milk is acceptable)'}, 'identificationModule': {'nctId': 'NCT03524469', 'briefTitle': 'Studying Infant Nutrition and Blood Sugar', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Studying Infant Nutrition and Glycemia (SING)', 'orgStudyIdInfo': {'id': 'RSRB71535'}, 'secondaryIdInfos': [{'id': 'K01DK115710', 'link': 'https://reporter.nih.gov/quickSearch/K01DK115710', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weight', 'description': '"Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test.'}, {'label': 'Insulin resistant', 'description': '"Insulin Resistance" will be defined as meeting any of the following:\n\n* pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test\n* pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth.\n* pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy\n* pre-pregnant BMI ≥ 30, and unmediated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Center of the University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'The Gerber Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Bridget Young', 'investigatorAffiliation': 'University of Rochester'}}}}