Diabetes, GestationalNCT02668601
Maternal GDM in Hispanic Youth: Risk for Obesity
An observational study of Diabetes, Gestational and Obesity, run by University of Southern California.
Trial summary
Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin… Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational, Obesity, Insulin Resistance
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: GDM exposed and non-exposed Hispanic offspring of singleton pregnancies between the ages of 4 to 18 years old. Offspring are the children of women with a history of GDM or with normal glucose levels during pregnancy who participated in the BetaGene Study. Normal glucose levels during pregnancy are defined as 1-hour 50g glucose challenge test <120 mg/dl. GDM diagnosis is defined as two or more abnormal values on 3-h 100-g diagnostic OGTT. GDM defined by American Diabetes Association Criteria in place from 2003-2008.
Who may be able to join
- Offspring between the ages of 4 and 18 years old who were born to women who participated in the BetaGene Study.
Who cannot join
- Offspring < 4 or > 18 years of age;
- gestation < 36 weeks at birth;
- significant medical illness and/or current use of medication known to influence glucose tolerance or BMI.
About this study
Official title: Maternal Gestational Diabetes in Hispanic Youth: Obesity and Insulin Resistance
Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage. In a subset of this cohort, we will also examine the effects of intrauterine exposure to gestational diabetes on the brain pathways that regulate appetite and body weight in children ages 6 to 15 years old.
Read the detailed description
Obesity rates have increased dramatically over the last two decades, particularly in children. Obesity is a major risk factor for type 2 diabetes (T2D), and there is a disproportionate prevalence of obesity and T2D in people of Hispanic origin. While a number of factors contribute to the development of obesity and T2D there is compelling evidence suggesting a profound role of the diabetic in utero environment. Epidemiological studies show that exposure to maternal diabetes in utero is associated with a significant risk of developing obesity and diabetes later in life. Provocative studies in animal models suggest that metabolic imprinting resulting from exposure to the altered metabolic milieu of diabetes in pregnancy leads to abnormalities in the development of specific fetal tissues, including the hypothalamus and pancreatic islets. Based on these findings, the goal of this research is to test the hypothesis that exposure to maternal gestational diabetes mellitus in utero results in changes during intrauterine development that mediate increased risk for obesity and diabetes. Through our ongoing studies on the genetics of type 2 diabetes we have access to hundreds of Hispanic offspring of well characterized GDM and control mothers. We are, therefore, in the unique position to perform mechanistic studies examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children and adolescents. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage.
To examine the effects of exposure to GDM on brain pathways involved in the regulation of energy homeostasis, we will perform additional functional magnetic resonance imaging (fMRI) studies in a subset of the larger cohort.
- Conditions
- Diabetes, Gestational, Obesity, Insulin Resistance, Insulin Secretion
- Keywords
- Gestational Diabetes Mellitus, Childhood Obesity, Offspring
- Medical subject headings
- Diabetes, Gestational, Obesity, Insulin Resistance, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GDM Exposed | Children exposed to gestational diabetes in utero | |
| Non-GDM Exposed | Children not exposed to gestational diabetes in utero |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiposity
BMI (z-score) and total body fat
Measured: Day 1
insulin sensitivity
OGTT
Measured: Day 2
insulin secretion
OGTT
Measured: Day 2
hypothalamic CBF
fMRI
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startAug 2010
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Page, University of Southern California
- Investigators
- Kathleen Page, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668601
- Sponsor's protocol ID
- HS-10-00465
- Status last verified
- Apr 2019
- First submitted
- 11 May 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Gestational Diabetes in Hispanic Youth: Obesity and Insulin Resistance
- ClinicalTrials.gov ID
- NCT02668601
- Acronym / sponsor ID
- HS-10-00465
- Conditions
- Diabetes, Gestational, Obesity, Insulin Resistance, Insulin Secretion
- Keywords
- Gestational Diabetes Mellitus, Childhood Obesity, Offspring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage. In a subset of this cohort, we will also examine the effects of intrauterine exposure to gestational diabetes on the brain pathways that regulate appetite and body weight in children ages 6 to 15 years old.
Detailed description
Obesity rates have increased dramatically over the last two decades, particularly in children. Obesity is a major risk factor for type 2 diabetes (T2D), and there is a disproportionate prevalence of obesity and T2D in people of Hispanic origin. While a number of factors contribute to the development of obesity and T2D there is compelling evidence suggesting a profound role of the diabetic in utero environment. Epidemiological studies show that exposure to maternal diabetes in utero is associated with a significant risk of developing obesity and diabetes later in life. Provocative studies in animal models suggest that metabolic imprinting resulting from exposure to the altered metabolic milieu of diabetes in pregnancy leads to abnormalities in the development of specific fetal tissues, including the hypothalamus and pancreatic islets. Based on these findings, the goal of this research is to test the hypothesis that exposure to maternal gestational diabetes mellitus in utero results in changes during intrauterine development that mediate increased risk for obesity and diabetes. Through our ongoing studies on the genetics of type 2 diabetes we have access to hundreds of Hispanic offspring of well characterized GDM and control mothers. We are, therefore, in the unique position to perform mechanistic studies examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children and adolescents. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage.
To examine the effects of exposure to GDM on brain pathways involved in the regulation of energy homeostasis, we will perform additional functional magnetic resonance imaging (fMRI) studies in a subset of the larger cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM Exposed | – | –Children exposed to gestational diabetes in utero |
| Non-GDM Exposed | – | –Children not exposed to gestational diabetes in utero |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- GDM exposed and non-exposed Hispanic offspring of singleton pregnancies between the ages of 4 to 18 years old. Offspring are the children of women with a history of GDM or with normal glucose levels during pregnancy who participated in the BetaGene Study. Normal glucose levels during pregnancy are defined as 1-hour 50g glucose challenge test <120 mg/dl. GDM diagnosis is defined as two or more abnormal values on 3-h 100-g diagnostic OGTT. GDM defined by American Diabetes Association Criteria in place from 2003-2008.
Key inclusion criteria (1 listed)
- Offspring between the ages of 4 and 18 years old who were born to women who participated in the BetaGene Study.
Key exclusion criteria (3 listed)
- Offspring < 4 or > 18 years of age;
- gestation < 36 weeks at birth;
- significant medical illness and/or current use of medication known to influence glucose tolerance or BMI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adiposity
Time frame: Day 1
BMI (z-score) and total body fat
insulin sensitivity
Time frame: Day 2
OGTT
insulin secretion
Time frame: Day 2
OGTT
hypothalamic CBF
Time frame: Day 3
fMRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Page, MD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Gestational and Obesity, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adiposity (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.