An observational study in Diabetes Mellitus, Obesity and Fatty Liver, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 1 Day to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
Among 80 studies in Diabetes Mellitus by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — 8 open to participants now, 12 under way, 1 of them phase 3. Diabetes Mellitus · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Among the 80 studies in Diabetes Mellitus by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), this one is the 10th largest by planned enrollment of the 22 observational ones, is one of 2 that started in 2022, is one of 18 observational ones, and was the 75th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →8 of the 80 studies in Diabetes Mellitus by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) are open now, in 1 country. Each count lists the studies.
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 1 Day to 99 Years · all sexes · healthy volunteers too.
The full table on the hub →80 studies; the count open now beside each. This study's row is marked.
First in 1976; this study’s year is marked. 2 started in 2022.
Median enrollment 100 across the 53 interventional studies, 1,100 across the 22 observational. Of the 65 that completed or were terminated, 14 (22%) have results posted.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
2 of the studies in Diabetes Mellitus by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT02262806National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy | 2027-07-31 |
Among the 80 studies in Diabetes Mellitus by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Study Description:
The current project will establish a longitudinal cohort of mother/infant/child dyads among American Indian/Alaska Native (AI/AN) and Hispanic ethnic groups, to study the role of a combination of biological and environmental factors on infant/childhood obesity and cardio metabolic risk.
Objectives:
Primary Objective: Primary Objective: To study the associations of maternal risk factors, including pre-pregnancy body mass index, gestational weight gain, and glycemia during pregnancy with offspring birth weight, length, and age/sex adjusted Body Mass Index (BMI) percentile and z-score up to 24-months of age.
Secondary Objectives:
To examine the relationship between maternal risk factors, early childhood exposures and changes in gut microbiome during,
infancy, childhood and adolescence.
Endpoints:
Primary Endpoint: Birth weight, length, and age/sex adjusted BMI percentile and z-score up to 24-months of age (time points: 6-12
weeks, 4, 6, 12, 18, and 24 months).
Secondary Endpoints: BMI percentile and z-scores 2 years to 18 years, biochemical measures, stool microbiome, neurocognitive
development.
Pregnant women from the Phoenix, AZ area
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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:
Children of mothers enrolled in the study
Pregnant women/mothers
Infant BMI
Birth weight, length, and age/sex adjusted BMI percentile and z-score up to 24-months of age (time points: 6-12 weeks, 4, 6, 12, 18 and 24 months).
Time frame: Birth, 6 weeks, and 4, 6, 12, 18 and 24 months
Child BMI
Child BMI measured annually from 2 years of age to 18 years of age
Time frame: annually from age 2 to 18
Plan to share: Yes — This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.
Supporting information: Study protocol, Informed consent form
Time frame: Data from this study may be requested from other researchers 1 year after the completion of the primary endpoint by contacting the Principal Investigator.
Access criteria: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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