Studying Infant Nutrition and Blood Sugar
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03524469|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 27, 2018
|Condition or disease|
|Insulin Resistance Obesity|
|Study Type :||Observational|
|Estimated Enrollment :||128 participants|
|Official Title:||Studying Infant Nutrition and Glycemia (SING)|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
"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.
"Insulin Resistance" will be defined as meeting any of the following:
- mean infant postprandial C peptide to creatinine ratio [ Time Frame: 2 weeks ]Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.
- mean infant insulinogenic index [ Time Frame: 5 months ]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.
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): NCT03524469
|Contact: Kaili Study Coordinator||585-275-8991||BreastFeedingStudy@urmc.rochester.edu|
|United States, New York|
|Clinical Research Center of the University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Ann Miller 585-275-2907 firstname.lastname@example.org|