Madhumita Sinha, M.D.

Head:
Diabetes Epidemiology and Clinical Research Section, Phoenix Epidemiology & Clinical Research Branch
Scientific Focus Areas: Clinical Research, Epidemiology, Health Disparities, Social and Behavioral Sciences
Clinical Trials
Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
- Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
- Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants are not being recruited or enrolled.
- Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate. The study is not open to everyone who meets the eligibility criteria.
- Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
Studies Seeking Patients
Early Tracking of Childhood Health Determinants (ETCHED) Study
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.
The trial is Open with a status of Recruiting.
Investigator: Madhumita Sinha, M.D.
Referral Contacts: Madhumita Sinha, M.D. (602) 200-5307
Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
This study will evaluate a behavioral intervention designed to reduce risk factors for type 2
diabetes in American Indian youth aged 7-10 years.
The trial is Open with a status of Active, not recruiting.
Investigator: Katherine Sauder, PhD