Gestational DiabetesNCT00534105
Lipid Metabolism in Gestational Diabetes
An observational study of Gestational Diabetes and Hyperlipidemia, run by Baystate Medical Center at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine… Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes, Hyperlipidemia
- What is being tested?
- Total Cholesterol, Triglyceride and HDL
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant women
Who may be able to join
- Pregnancy
- Abnormal one hour glucose challenge test
- "Normal" controls group one hour test between 135 mg% and 150 mg%
- "Gestational diabetic" group with two abnormal values on a 3 hour GTT
Who cannot join
- History of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
- Prior history of lipid disorder or metabolic syndrome
- Current medications thought to adversely influence glucose tolerance (i.e. prednisone or other steroids and systemic beta-mimetic drugs)
- Non-singleton pregnancy
- < 16 years of age or over 40 years of age
- Not planning to deliver at Baystate Medical Center
- Twins
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Study of Lipid Metabolism in Gestational Diabetes
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored.
This will be a prospective cohort study. As part of routine prenatal care, women receive a one hour glucose challenge test to screen for gestational diabetes. Those women with elevated values then require a three hour glucose tolerance test, which is a diagnostic test for gestational diabetes. All women that are scheduled to receive a three hour GTT will be identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal groups will be asked to return 6-8 weeks
Read the detailed description
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored. Subsequent studies could also explore the possible perinatal complications associated with elevated lipids and or metabolic syndrome.
- Experimental Design, Methodology and Expected Results
Study Design:
We propose a prospective cohort design.
Study Population:
All women that are scheduled to receive a three hour GTT to rule out gestational diabetes would be identified and ask to enroll in this study. Specifically, eligible patients will be women who failed their glucose challenge test (GCT) and are scheduled for the follow-up three hour glucose tolerance test (GTT). The GCT is routinely performed among all prenatal care patients at 24-28 wks gestation. The 3 hour GTT requires patients to be fasting overnight. A fasting blood glucose is sampled, and the patients are given a 100 gram glucose drink. Serum glucose samples are then taken at one, two and three hours after the glucose loading. The "exposed" group will be defined as women diagnosed with GDM (elevated glucose values on two or more samples in the three hour GTT). The "unexposed" group will be defined as women with no abnormal glucose values in the three hour GTT.
- Conditions
- Gestational Diabetes, Hyperlipidemia
- Being tested
- Total Cholesterol, Triglyceride, HDL, LDL
- Keywords
- Pregnancy, Gestational diabetes, Hyperlipidemia
- Medical subject headings
- Diabetes, Gestational, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total CholesterolOther
TriglycerideOther
HDLOther
LDLOther
| Study group | Role | What they receive |
|---|---|---|
| Gestational Diabetics | Patients with Gestational Diabetes Receives: Other: Total Cholesterol; Other: Triglyceride; Other: HDL; Other: LDL | |
| 2 | Normal pregnant women without gestational diabetes Receives: Other: Total Cholesterol; Other: Triglyceride; Other: HDL; Other: LDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
Measured: Postpartum
Secondary outcomes (3)
Triglyceride Values
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Measured: Postpartum
HDL
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Measured: Postpartum
LDL
LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Measured: Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational DiabetesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Markenson, Baystate Medical Center
- Investigators
- Glenn R Markenson, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534105
- Sponsor's protocol ID
- IRB07-121
- Status last verified
- Jul 2013
- First submitted
- 21 Sep 2007
- Last updated
- 11 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lipid Metabolism in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT00534105
- Acronym / sponsor ID
- IRB07-121
- Conditions
- Gestational Diabetes, Hyperlipidemia
- Keywords
- Pregnancy, Gestational diabetes, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Posted 11 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored.
This will be a prospective cohort study. As part of routine prenatal care, women receive a one hour glucose challenge test to screen for gestational diabetes. Those women with elevated values then require a three hour glucose tolerance test, which is a diagnostic test for gestational diabetes. All women that are scheduled to receive a three hour GTT will be identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal groups will be asked to return 6-8 weeks
Detailed description
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored. Subsequent studies could also explore the possible perinatal complications associated with elevated lipids and or metabolic syndrome.
- Experimental Design, Methodology and Expected Results
Study Design:
We propose a prospective cohort design.
Study Population:
All women that are scheduled to receive a three hour GTT to rule out gestational diabetes would be identified and ask to enroll in this study. Specifically, eligible patients will be women who failed their glucose challenge test (GCT) and are scheduled for the follow-up three hour glucose tolerance test (GTT). The GCT is routinely performed among all prenatal care patients at 24-28 wks gestation. The 3 hour GTT requires patients to be fasting overnight. A fasting blood glucose is sampled, and the patients are given a 100 gram glucose drink. Serum glucose samples are then taken at one, two and three hours after the glucose loading. The "exposed" group will be defined as women diagnosed with GDM (elevated glucose values on two or more samples in the three hour GTT). The "unexposed" group will be defined as women with no abnormal glucose values in the three hour GTT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational Diabetics | – | Other: Total Cholesterol, Other: Triglyceride, Other: HDL, Other: LDLPatients with Gestational Diabetes |
| 2 | – | Other: Total Cholesterol, Other: Triglyceride, Other: HDL, Other: LDLNormal pregnant women without gestational diabetes |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women
Key inclusion criteria (4 listed)
- Pregnancy
- Abnormal one hour glucose challenge test
- "Normal" controls group one hour test between 135 mg% and 150 mg%
- "Gestational diabetic" group with two abnormal values on a 3 hour GTT
Key exclusion criteria (7 listed)
- History of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
- Prior history of lipid disorder or metabolic syndrome
- Current medications thought to adversely influence glucose tolerance (i.e. prednisone or other steroids and systemic beta-mimetic drugs)
- Non-singleton pregnancy
- < 16 years of age or over 40 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Cholesterol | Other | 2, Gestational Diabetics |
| Triglyceride | Other | 2, Gestational Diabetics |
| HDL | Other | 2, Gestational Diabetics |
| LDL | Other | 2, Gestational Diabetics |
Primary outcome
Cholesterol
Time frame: Postpartum
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
3 secondary outcomes
Triglyceride Values
Time frame: Postpartum
HDL
Time frame: Postpartum
LDL
Time frame: Postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Glenn R Markenson, MD principal investigator
Baystate Medical Center
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 and Hyperlipidemia, run by Baystate Medical Center 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 4 inclusion and 7 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 11 Sep 2013. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cholesterol (time frame: Postpartum). 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 11 Sep 2013.