Protocol Details
Early Tracking of Childhood Health Determinants Study
This study is currently recruiting participants.
Summary
Number |
18-DK-N071 |
Sponsoring Institute |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: 99 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
White;
Native Hawaiian/Pacific Islander;
Black or African American;
Asian |
Keywords |
American Indians, Hispanics;
Obesity;
Pregnancy;
Diabetes;
Children;
Hispanics;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Diabetes Mellitus;
Obesity;
Fatty Liver |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Diabetes and Digestive and Kidney Diseases |
Background:
Children s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during and after pregnancy, and how these affect a child s development. They will also follow the mother s health and well-being after pregnancy.
Objectives:
To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her child s growth and development from birth until adulthood.
Eligibility:
American Indian/Alaska Native (AI/AN) or Hispanic adult pregnant women and their offspring.
Design:
Mothers will have 3 visits during pregnancy.
In the child s first year, mothers will have 2 visits and their child will have 4.
Children will have 2 visits in their second year and 1 each year until they turn 18.
Mothers will have a visit 2 years after birth and 4-5 years later.
Both the mother and child s medical records will be reviewed. They will have physical exams and give blood and stool samples.
Mothers may give cord blood and placenta samples. They will give breastmilk and urine samples. They will fill out questionnaires.
They will have an ultrasound. They may get an activity monitor.
Mother and child will be followed until the child s 18th birthday.
Eligibility
INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination)
2. American Indian or Hispanic by self-report
3. Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery.
In case where a pregnant mother is carrying multiple fetuses (multiple pregnancy), she will be eligible to participate in this study and all her live newborns, as a result of that pregnancy, will be eligible for participation in this study. Mothers will also be eligible to participate with any consecutive pregnancies.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Women who are incarcerated or are unable to consent.
2. Women whose fetus is not viable or are not planning to continue the pregnancy.
Citations:
Pettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8.
Dabelea D, Hanson RL, Lindsay RS, Pettitt DJ, Imperatore G, Gabir MM, Roumain J, Bennett PH, Knowler WC. Intrauterine exposure to diabetes conveys risks for type 2 diabetes and obesity: a study of discordant sibships. Diabetes. 2000 Dec;49(12):2208-11.
Pettitt DJ, Baird HR, Aleck KA, Bennett PH, Knowler WC. Excessive obesity in offspring of Pima Indian women with diabetes during pregnancy. N Engl J Med. 1983 Feb 3;308(5):242-5.
Contacts:
Clinical Trials Number:
NCT03481829