PregnancyNCT02282475
Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy
An observational study of Pregnancy and Gestational Diabetes, run by Kaiser Permanente.
Trial summary
Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. This study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes, Obesity
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2014to 31 Dec 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women ages 18-40 years and actively enrolled in Kaiser Permanente Northwest (KPNW).
Who may be able to join
- Pregnant and enrolled members of Kaiser
Who cannot join
- Women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease.
- Non-English speaker
About this study
Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. This study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during pregnancy.
Read the detailed description
This study aims to serially evaluate liver and visceral fat stores during pregnancy and their relationship with glucose and lipid metabolism, placental function, and newborn size. To do this we will conduct both a prospective cohort study of pregnant women without pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at 32-36 weeks gestation and a case-control study of women with normal and impaired glucose tolerance in the early third trimester. Physical assessments will be performed by the Oregon Health and Science University bio-nutrition unit and will include the use of magnetic resonance imaging, ultrasound, and blood draws.
- Conditions
- Pregnancy, Gestational Diabetes, Obesity, Liver Fat
- Medical subject headings
- Diabetes, Gestational, Obesity, Fatty Liver
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 |
|---|---|---|
| Cohort study of pregnant women | Participants will complete the following at 12-16 weeks gestation and again at 32-36 weeks gestation: 1. Fasting glucose, insulin and insulin sensitivity testing; 2. Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism; 3. Measurements of body fat using air displacement technology and MRI; 4. Ultrasound to measure placental blood flow, visceral fat thickness (12-16 weeks only) and to estimate fetal weight (32-36 weeks only); 5. 24 hour diet recalls 6. Questionaires regarding activity level | |
| Case-control study Gestational Diabetes | Participants diagnosed with gestational diabetes (cases) and without gestational diabetes (controls) will complete the following at 32-36 weeks gestation: 1. Fasting glucose, insulin and insulin sensitivity testing; 2. Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism; 3. Measurements of body fat by using air displacement technology and MRI; 4. Ultrasound to measure placental blood flow and to estimate fetal weight; 5. 24 hour diet recalls 6. Questionaires regarding activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy
We will compare visceral adipose fat and intrahepatic lipid levels in early pregnancy (12-16 weeks gestation) to late pregnancy (32-36 weeks gestation). This will done by comparing changes in accumulation of fat in the visceral adipose tissue, changes in intrahepatic lipid values and changes in total body fat in early and late pregnancy. We will be collecting body composition measurements and utilizing ultrasound and Magnetic Resonance Imaging.
Measured: 12-16 weeks and 32-36 weeks gestation
Secondary outcomes (1)
Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance
We will use a matched case-control design with matching for body mass index to compare intrahepatic lipid, visceral adipose tissue, total body fat, and insulin sensitivity among women with gestational diabetes and normal glucose tolerance, as measured at 32-36 weeks gestation.
Measured: 34 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study start30 Nov 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Kim Vesco, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282475
- Sponsor's protocol ID
- 1R01DK098707-01A1
- Status last verified
- Jan 2019
- First submitted
- 28 Oct 2014
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy
- ClinicalTrials.gov ID
- NCT02282475
- Acronym / sponsor ID
- 1R01DK098707-01A1
- Conditions
- Pregnancy, Gestational Diabetes, Obesity, Liver Fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 30 Nov 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Nov 2014 (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.
Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. This study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during pregnancy.
Detailed description
This study aims to serially evaluate liver and visceral fat stores during pregnancy and their relationship with glucose and lipid metabolism, placental function, and newborn size. To do this we will conduct both a prospective cohort study of pregnant women without pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at 32-36 weeks gestation and a case-control study of women with normal and impaired glucose tolerance in the early third trimester. Physical assessments will be performed by the Oregon Health and Science University bio-nutrition unit and will include the use of magnetic resonance imaging, ultrasound, and blood draws.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort study of pregnant women | – | –Participants will complete the following at 12-16 weeks gestation and again at 32-36 weeks gestation: 1. Fasting glucose, insulin and insulin sensitivity testing; 2. Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism; 3. Measurements of body fat using air displacement technology and MRI; 4. Ultrasound to measure placental blood flow, visceral fat thickness (12-16 weeks only) and to estimate fetal weight (32-36 weeks only); 5. 24 hour diet recalls 6. Questionaires regarding activity level |
| Case-control study Gestational Diabetes | – | –Participants diagnosed with gestational diabetes (cases) and without gestational diabetes (controls) will complete the following at 32-36 weeks gestation: 1. Fasting glucose, insulin and insulin sensitivity testing; 2. Blood tests for cholesterol and fatty acids, liver function, inflammation, and markers of metabolism; 3. Measurements of body fat by using air displacement technology and MRI; 4. Ultrasound to measure placental blood flow and to estimate fetal weight; 5. 24 hour diet recalls 6. Questionaires regarding activity level |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women ages 18-40 years and actively enrolled in Kaiser Permanente Northwest (KPNW).
Key inclusion criteria (1 listed)
- Pregnant and enrolled members of Kaiser
Key exclusion criteria (2 listed)
- Women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease.
- Non-English speaker
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
Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy
Time frame: 12-16 weeks and 32-36 weeks gestation
We will compare visceral adipose fat and intrahepatic lipid levels in early pregnancy (12-16 weeks gestation) to late pregnancy (32-36 weeks gestation). This will done by comparing changes in accumulation of fat in the visceral adipose tissue, changes in intrahepatic lipid values and changes in total body fat in early and late pregnancy. We will be collecting body composition measurements and utilizing ultrasound and Magnetic Resonance Imaging.
1 secondary outcome
Compare glucose tolerance in pregnant women with gestational diabetes to those with normal glucose tolerance
Time frame: 34 weeks gestation
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 24 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Kim Vesco, MD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Gestational Diabetes, run by Kaiser Permanente.
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 2 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 24 Jan 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?
Assess visceral adipose fat and intrahepatic lipid stores change during pregnancy (time frame: 12-16 weeks and 32-36 weeks gestation). 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 24 Jan 2019.