Diabetes Mellitus, Type 2COPSS-GDMNCT00849849
Comprehensive Postpartum Screening Strategies for Women With Gestational Diabetes Mellitus (GDM)
An observational study of Diabetes Mellitus, Type 2, run by Woman's at 1 site in United States.
Trial summary
Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2013
- 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
- Healthy volunteers accepted
- Adult
Study population: Postpartum women with GDM (before 12 weeks postpartum)
Who may be able to join
- Postpartum Women (6-12 weeks)who experienced GDM during index pregnancy 18 years to 42 years of age
- English-speaking
- Written consent for participation in the study
Who cannot join
- Cholestasis during the past pregnancy
- Serum AST and/or ALT level exceeding more than twice normal laboratory values
- History or clinical manifestation of cardiovascular disease
- History or clinical manifestation of diabetes or use of anti-diabetic drugs before pregnancy
- History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
- Regular use of medications for weight control, psychosis and hormonal birth control
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- Current use of medication to treat diabetes
- History or clinical manifestation of any eating disorder
- Individuals who smoke
- History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
- Other Exclusion Criteria:
- Pregnancy or pregnancy planned during the coming year
- Not willing or unable to adhere to the clinical evaluation schedule over the twelve -month study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Woman's Hospital Research Institute
Baton Rouge, Louisiana, 70815
About this study
Official title: Comprehensive Postpartum Screening Strategies for Women With Prior Gestational Diabetes (COPSS - GDM): Now is the Time for a Paradigm Shift in Clinical Practice
Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a history of GDM vary widely depending on the length of follow up and the underlying risk of diabetes in the population. Like DM2, the incidence of postpartum diabetes appears to be increasing The cumulative incidence of DM2 varied from 2.6 to > 70% in studies with postpartum follow-up ranging from 6 weeks to 28 years. Among women with a history of gestational diabetes, it is generally accepted that race, age, parity, family history of diabetes, pre-pregnancy weight, postpartum obesity, and weight gain are risk factors for developing DM2. Other suspected risk factors include smoking, physical inactivity, diet, and drugs that adversely affect glucose metabolism. Despite the high and increasing rate of DM2 in Louisiana, the medical community does not have reliable estimates of the number of woman living in southern Louisiana who develop diabetes subsequent to GDM. At Woman's Hospital, the investigators had 8246 deliveries in 2007; 7873 mothers (95% of deliveries) were either African American or Caucasian. Of this group of women, 665 were diagnosed with gestational diabetes mellitus. Thus, around 8.5% of the African American and Caucasian women delivering babies at Woman's Hospital in 2007 had a glucose abnormality. The incidence of diabetes and impaired glucose metabolism in the immediate postpartum period and within 12 months after delivery in this population is unknown. There are no long-term studies performed in Louisiana that have compared the benefits of different screening strategies or evaluated an optimum testing frequency after GDM to reduce the rate of DM2 and cardiovascular disease (CVD) in these high-risk women. The investigators plan to use this study as an outreach effort to provide screening for previous gestational diabetic mothers without adequate medical coverage following delivery.
Read the detailed description
Women with previous gestational diabetes constitute an ideal group for the development, testing, and implementation of clinical strategies for primary diabetes prevention. One-third to one-half of women with a history of GDM will develop type 2 (DM2) within 3-5 years and 70% will develop DM2 if followed >10 years. Studies have shown that measuring only the fasting glucose level postpartum is not sufficiently sensitive to identify all women who have impaired glucose tolerance (IGT) or DM2. Data presented at the Fifth International Workshop-Conference on GDM indicated that, postpartum, only 34% of the women with IGT or DM2 had impaired fasting glucose and that 44% of those with DM2 had fasting levels below 100 mg/dl (<5.5 mmol/l). The recommended process to detect permanent diabetes in women who have had GDM and who might become pregnant again is a 75-g 2-h oral glucose tolerance test (OGTT) 6-12 weeks post partum and every year thereafter. Postpartum management of women with GDM is critical because of their markedly increased risk of DM2 and its comorbidities in the future Follow-up studies of women with GDM are necessary to establish the most efficient and most-effective approach to postpartum screening for type 2 diabetes. This study will examine the diagnostic effectiveness of OGTT-derived glucose tolerance, insulin secretion and insulin sensitivity indices compared with indices derived from fasting values of glucose and insulin in subjects with GDM performed post-partum. We will establish whether post-partum fasting and/or glucose-stimulated indices of insulin sensitivity and secretion most accurately estimate the degree of insulin resistance relative to ß-cell function in all race/ethnicity groups of women after delivery of a pregnancy complicated by gestational diabetes and predict their risk for development of diabetes and CVD. .Primary Objective1) We will identify, recruit and test 100 individuals with prior GDM in order to:§ Determine the best way to assess glucose tolerance disorders' prevalence after pregnancy complicated by GDM in southern Louisiana.§ Determine the most effective screening strategy to identify those women with prior GDM who develop or are at high risk for developing DM2 and comorbidities postpartum.A 2 hr, 75-gram OGTT with measurements of insulin and glucose will be performed at their 6-12 week and 1-year post-delivery check-up; this will be compared with the results of their single fasting glucose and insulin value.Secondary Objectives1) We will measure cardiometabolic markers (lipids, blood pressure) in the COPS-GDM study in order to:§ Identify the frequency and value of CVD risk markers in women with glucose abnormalities persisting after pregnancies with GDMGlucometabolic perturbations carry a particularly high risk for metabolic syndrome in women with prior GDM. Woman with prior GDM shown to have higher blood pressure and an altered lipid profile with increased LDL cholesterol and triglyceride levels and decreased HDL cholesterol levels that correlate with cardiovascular disease (CVD) risk factors2) We will measure anthropometric measures (body weight, BMI, abdominal girth) and liver aminotransferase levels (ALT, AST) in order to:§ Determine if there is a higher prevalence of postpartum glucose abnormalities in women with prior GDM predicted by BMI category and/or abdominal adiposity § Determine if elevated abnormal aminotransferase activity is more prominent in prior GDM women and the relationship to subsequent diabetes Former gestational diabetic mothers when compared with women with no history of GDM are found to have higher body mass index (BMI) and visceral adiposity. The distribution of postpartum glucose abnormalities by BMI category was found to be more common with increased BMI.3) We will investigate the impact of breastfeeding in women with a prior GDM on glucose tolerance and CVD risk factors to:§ Determine if lactation has immediate and long-term favorable effects in this patient population postpartum.Breast-feeding has been associated with significantly lower triglyceride level, higher HDL cholesterol, lower total cholesterol/HDL ratio, lower mean fasting glucose, and lower prevalence of any postpartum abnormality of glucose tolerance, including diabetes. Breastfeeding has also been reported to lower the rate of overt diabetes developing later in life in women with a history of gestational diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- postgestational diabetes, diabetes mellitus, OGTT, insulin sensitivity, insulin secretion
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, 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 |
|---|---|---|
| Postpartum GDM OGTT | 200 women with prior GDM in their index pregnancies will undergo postpartum screening assessment. This program will follow these women who are at a high risk of developing DM2 after delivery for 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine best way to assess glucose disorder prevalence in women with prior GDM
A 2 hr, 75-gram OGTT with measurements of insulin and glucose will be performed at their 6-12 week and 1-year post-delivery check-up; this will be compared with the results of their single fasting glucose and insulin value.
Measured: 3 years
Secondary outcomes (1)
Investigate if cardiometabolic markers-lipid profile and blood pressure anthropometric markers such as BMI [BMI, absolute body weight]; visceral adiposity as assessed by abdominal girth are associated with an increased diabetes risk
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Elkind-Hirsch, Woman's
- Investigators
- Karen E Elkind-Hirsch, MSc,PhD, Principal investigator, Woman's Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849849
- Sponsor's protocol ID
- RO-08-11
- Acronym
- COPSS-GDM
- Status last verified
- Dec 2014
- First submitted
- 23 Feb 2009
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- Comprehensive Postpartum Screening Strategies for Women With Prior Gestational Diabetes (COPSS - GDM): Now is the Time for a Paradigm Shift in Clinical Practice
- ClinicalTrials.gov ID
- NCT00849849
- Acronym / sponsor ID
- COPSS-GDM / RO-08-11
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- postgestational diabetes, diabetes mellitus, OGTT, insulin sensitivity, insulin secretion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Feb 2009 (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.
Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a history of GDM vary widely depending on the length of follow up and the underlying risk of diabetes in the population. Like DM2, the incidence of postpartum diabetes appears to be increasing The cumulative incidence of DM2 varied from 2.6 to > 70% in studies with postpartum follow-up ranging from 6 weeks to 28 years. Among women with a history of gestational diabetes, it is generally accepted that race, age, parity, family history of diabetes, pre-pregnancy weight, postpartum obesity, and weight gain are risk factors for developing DM2. Other suspected risk factors include smoking, physical inactivity, diet, and drugs that adversely affect glucose metabolism. Despite the high and increasing rate of DM2 in Louisiana, the medical community does not have reliable estimates of the number of woman living in southern Louisiana who develop diabetes subsequent to GDM. At Woman's Hospital, the investigators had 8246 deliveries in 2007; 7873 mothers (95% of deliveries) were either African American or Caucasian. Of this group of women, 665 were diagnosed with gestational diabetes mellitus. Thus, around 8.5% of the African American and Caucasian women delivering babies at Woman's Hospital in 2007 had a glucose abnormality. The incidence of diabetes and impaired glucose metabolism in the immediate postpartum period and within 12 months after delivery in this population is unknown. There are no long-term studies performed in Louisiana that have compared the benefits of different screening strategies or evaluated an optimum testing frequency after GDM to reduce the rate of DM2 and cardiovascular disease (CVD) in these high-risk women. The investigators plan to use this study as an outreach effort to provide screening for previous gestational diabetic mothers without adequate medical coverage following delivery.
Detailed description
Women with previous gestational diabetes constitute an ideal group for the development, testing, and implementation of clinical strategies for primary diabetes prevention. One-third to one-half of women with a history of GDM will develop type 2 (DM2) within 3-5 years and 70% will develop DM2 if followed >10 years. Studies have shown that measuring only the fasting glucose level postpartum is not sufficiently sensitive to identify all women who have impaired glucose tolerance (IGT) or DM2. Data presented at the Fifth International Workshop-Conference on GDM indicated that, postpartum, only 34% of the women with IGT or DM2 had impaired fasting glucose and that 44% of those with DM2 had fasting levels below 100 mg/dl (<5.5 mmol/l). The recommended process to detect permanent diabetes in women who have had GDM and who might become pregnant again is a 75-g 2-h oral glucose tolerance test (OGTT) 6-12 weeks post partum and every year thereafter. Postpartum management of women with GDM is critical because of their markedly increased risk of DM2 and its comorbidities in the future Follow-up studies of women with GDM are necessary to establish the most efficient and most-effective approach to postpartum screening for type 2 diabetes. This study will examine the diagnostic effectiveness of OGTT-derived glucose tolerance, insulin secretion and insulin sensitivity indices compared with indices derived from fasting values of glucose and insulin in subjects with GDM performed post-partum. We will establish whether post-partum fasting and/or glucose-stimulated indices of insulin sensitivity and secretion most accurately estimate the degree of insulin resistance relative to ß-cell function in all race/ethnicity groups of women after delivery of a pregnancy complicated by gestational diabetes and predict their risk for development of diabetes and CVD. .Primary Objective1) We will identify, recruit and test 100 individuals with prior GDM in order to:§ Determine the best way to assess glucose tolerance disorders' prevalence after pregnancy complicated by GDM in southern Louisiana.§ Determine the most effective screening strategy to identify those women with prior GDM who develop or are at high risk for developing DM2 and comorbidities postpartum.A 2 hr, 75-gram OGTT with measurements of insulin and glucose will be performed at their 6-12 week and 1-year post-delivery check-up; this will be compared with the results of their single fasting glucose and insulin value.Secondary Objectives1) We will measure cardiometabolic markers (lipids, blood pressure) in the COPS-GDM study in order to:§ Identify the frequency and value of CVD risk markers in women with glucose abnormalities persisting after pregnancies with GDMGlucometabolic perturbations carry a particularly high risk for metabolic syndrome in women with prior GDM. Woman with prior GDM shown to have higher blood pressure and an altered lipid profile with increased LDL cholesterol and triglyceride levels and decreased HDL cholesterol levels that correlate with cardiovascular disease (CVD) risk factors2) We will measure anthropometric measures (body weight, BMI, abdominal girth) and liver aminotransferase levels (ALT, AST) in order to:§ Determine if there is a higher prevalence of postpartum glucose abnormalities in women with prior GDM predicted by BMI category and/or abdominal adiposity § Determine if elevated abnormal aminotransferase activity is more prominent in prior GDM women and the relationship to subsequent diabetes Former gestational diabetic mothers when compared with women with no history of GDM are found to have higher body mass index (BMI) and visceral adiposity. The distribution of postpartum glucose abnormalities by BMI category was found to be more common with increased BMI.3) We will investigate the impact of breastfeeding in women with a prior GDM on glucose tolerance and CVD risk factors to:§ Determine if lactation has immediate and long-term favorable effects in this patient population postpartum.Breast-feeding has been associated with significantly lower triglyceride level, higher HDL cholesterol, lower total cholesterol/HDL ratio, lower mean fasting glucose, and lower prevalence of any postpartum abnormality of glucose tolerance, including diabetes. Breastfeeding has also been reported to lower the rate of overt diabetes developing later in life in women with a history of gestational diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum GDM OGTT | – | –200 women with prior GDM in their index pregnancies will undergo postpartum screening assessment. This program will follow these women who are at a high risk of developing DM2 after delivery for 1 year. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Postpartum women with GDM (before 12 weeks postpartum)
Key inclusion criteria (3 listed)
- Postpartum Women (6-12 weeks)who experienced GDM during index pregnancy 18 years to 42 years of age
- English-speaking
- Written consent for participation in the study
Key exclusion criteria (13 listed)
- Cholestasis during the past pregnancy
- Serum AST and/or ALT level exceeding more than twice normal laboratory values
- History or clinical manifestation of cardiovascular disease
- History or clinical manifestation of diabetes or use of anti-diabetic drugs before pregnancy
- History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
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
Determine best way to assess glucose disorder prevalence in women with prior GDM
Time frame: 3 years
A 2 hr, 75-gram OGTT with measurements of insulin and glucose will be performed at their 6-12 week and 1-year post-delivery check-up; this will be compared with the results of their single fasting glucose and insulin value.
1 secondary outcome
Investigate if cardiometabolic markers-lipid profile and blood pressure anthropometric markers such as BMI [BMI, absolute body weight]; visceral adiposity as assessed by abdominal girth are associated with an increased diabetes risk
Time frame: 3 years
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.
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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, MSc,PhD principal investigator
Woman's Health Research Institute
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 Diabetes Mellitus, Type 2, 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 13 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?
Determine best way to assess glucose disorder prevalence in women with prior GDM (time frame: 3 years). 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 18 Dec 2014.