Gestational Diabetes MellitusDRMNCT00687479
Insulin Action During Pregnancy in Woman at High Risk for Gestational Diabetes
An observational study of Gestational Diabetes Mellitus, run by Woman's at 1 site in United States.
Trial summary
The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2009
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy, nondiabetic pregnant African-American and Caucasian women who have been scheduled for a standard 3-hour glucose tolerance test at 24-28 weeks in the Woman's Hospital Pathology laboratory.
Who may be able to join
- 18-42 years of age
- at 20-30 weeks of gestation
- Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism.
Who cannot join
- <18 years or >42 years of age
- non-Caucasian or non-African-American ethnicity
- use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Woman's Hospital Pathology Laboratory
Baton Rouge, Louisiana, 70815
About this study
Official title: Clinically Useful Methods for Assessment of Insulin Sensitivity and Beta Cell Function in Women at High Risk for Gestational Diabetes: Does Race Matter?
The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that are potentially linked to complications during pregnancy and to increased risks of obesity and diabetes in later life. The investigators will explore the use of indexes of insulin status to identify the metabolic risk profile of pregnant women which may vary by race. Understanding whether there are differences which vary by race may influence clinical screening and treatment of pregnant women.
Read the detailed description
The major goal of our proposed study is to validate a new approach to estimating insulin sensitivity and ß-cell function in African-American women compared to non-Hispanic white women in southern Louisiana who are at a high risk for gestational diabetes mellitus (GDM). We will determine whether the whole body insulin sensitivity index (WBISI) and insulinogenic index (IGI) [derived from an oral glucose tolerance test (OGTT)] can be used during 24-28 weeks of pregnancy to accurately estimate the degree of insulin resistance relative to ß-cell function in women with GDM in those with impaired glucose tolerance (IGT) as well as those who are glucose tolerant. Fasting values will also be assessed using the homeostasis model assessment (HOMA-IR and HOMA-%B) to evaluate insulin resistance and ß-cell function. We will explore the potential use of these measures to define the metabolic risk profile of these pregnant women and compare them with obstetric outcomes. We will determine if there are differences in risk that vary by race. Second, given the high likelihood that women who manifest GDM will develop type 2 diabetes mellitus (DM), identification of these patients by ethnic group or other independent determinants will permit intervention after delivery that might delay or prevent the onset of type 2 DM.
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- insulin sensitivity, insulin secretion, infant outcome
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
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 |
|---|---|---|
| 1-NGT | normal glucose tolerance | |
| 2-GDM | Gestational Diabetes mellitus | |
| 3.GIGT | Gestational Impaired glucose tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin action measures
Measured: 20-30 weeks of pregnancy
Secondary outcomes (1)
infant gestational age
Measured: time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- Baton Rouge Area Foundation
- Responsible party
- Principal investigator, Karen Elkind-Hirsch, Woman's
- Investigators
- Karen E Elkind-Hirsch, Ph.D., Principal investigator, Woman's Health Research InstituteBeverly Ogden, MD, Principal investigator, Woman's Pathology Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687479
- Sponsor's protocol ID
- 05-013
- Acronym
- DRM
- Status last verified
- Dec 2014
- First submitted
- 28 May 2008
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirwan JP, Huston-Presley L, Kalhan SC, Catalano PM. Clinically useful estimates of insulin sensitivity during pregnancy: validation studies in women with normal glucose tolerance and gestational diabetes mellitus. Diabetes Care. 2001 Sep;24(9):1602-7. doi: 10.2337/diacare.24.9.1602.
PubMed 11522706
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Useful Methods for Assessment of Insulin Sensitivity and Beta Cell Function in Women at High Risk for Gestational Diabetes: Does Race Matter?
- ClinicalTrials.gov ID
- NCT00687479
- Acronym / sponsor ID
- DRM / 05-013
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- insulin sensitivity, insulin secretion, infant outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- Baton Rouge Area Foundation
- Study start
- Jan 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 May 2008 (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.
The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that are potentially linked to complications during pregnancy and to increased risks of obesity and diabetes in later life. The investigators will explore the use of indexes of insulin status to identify the metabolic risk profile of pregnant women which may vary by race. Understanding whether there are differences which vary by race may influence clinical screening and treatment of pregnant women.
Detailed description
The major goal of our proposed study is to validate a new approach to estimating insulin sensitivity and ß-cell function in African-American women compared to non-Hispanic white women in southern Louisiana who are at a high risk for gestational diabetes mellitus (GDM). We will determine whether the whole body insulin sensitivity index (WBISI) and insulinogenic index (IGI) [derived from an oral glucose tolerance test (OGTT)] can be used during 24-28 weeks of pregnancy to accurately estimate the degree of insulin resistance relative to ß-cell function in women with GDM in those with impaired glucose tolerance (IGT) as well as those who are glucose tolerant. Fasting values will also be assessed using the homeostasis model assessment (HOMA-IR and HOMA-%B) to evaluate insulin resistance and ß-cell function. We will explore the potential use of these measures to define the metabolic risk profile of these pregnant women and compare them with obstetric outcomes. We will determine if there are differences in risk that vary by race. Second, given the high likelihood that women who manifest GDM will develop type 2 diabetes mellitus (DM), identification of these patients by ethnic group or other independent determinants will permit intervention after delivery that might delay or prevent the onset of type 2 DM.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-NGT | – | –normal glucose tolerance |
| 2-GDM | – | –Gestational Diabetes mellitus |
| 3.GIGT | – | –Gestational Impaired glucose tolerance |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, nondiabetic pregnant African-American and Caucasian women who have been scheduled for a standard 3-hour glucose tolerance test at 24-28 weeks in the Woman's Hospital Pathology laboratory.
Key inclusion criteria (3 listed)
- 18-42 years of age
- at 20-30 weeks of gestation
- Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism.
Key exclusion criteria (3 listed)
- <18 years or >42 years of age
- non-Caucasian or non-African-American ethnicity
- use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases
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
Insulin action measures
Time frame: 20-30 weeks of pregnancy
1 secondary outcome
infant gestational age
Time frame: time of delivery
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 18 Dec 2014.
- Background: PubMed 11522706Kirwan JP, Huston-Presley L, Kalhan SC, Catalano PM. Clinically useful estimates of insulin sensitivity during pregnancy: validation studies in women with normal glucose tolerance and gestational diabetes mellitus. Diabetes Care. 2001 Sep;24(9):1602-7. doi: 10.2337/diacare.24.9.1602.
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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.
Karen E Elkind-Hirsch, Ph.D. principal investigator
Woman's Health Research Institute
Beverly Ogden, MD principal investigator
Woman's Pathology Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Woman's at 1 site in United States.
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 3 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Insulin action measures (time frame: 20-30 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00687479, which also lists 1 linked publication.
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 18 Dec 2014.