Gestational Diabetes MellitusSPRINGNCT02763267
Study of Pregnancy Regulation of Insulin and Glucose
An observational study of Gestational Diabetes Mellitus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2021
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: 150 Pregnant Women with history of GDM or at risk for diabetes mellitus and 200 Nonpregnant Women with history of GDM
Who may be able to join
- Women, age 18-44, non-pregnant OR in the 1st trimester of pregnancy (4-14 weeks gestation),
- Who had GDM in a previous pregnancy
- At risk for diabetes mellitus, as specified by the American Diabetes Association (ADA):
- BMI ≥ 25 kg/m2 (or BMI ≥ 23 kg/m2 if Asian-American) PLUS one or more of the following:
- history of giving birth to a neonate weighing > 9 lbs
- first-degree family member with diabetes mellitus
Show all 10Show fewer
- high-risk ethnic or racial group (African-American, Hispanic, Native American, Asian-American, or Pacific Islander)
- polycystic ovary syndrome
- hypertension, dyslipidemia if known (HDL<45 and/or triglyceride level >250), or cardiovascular disease
- physical inactivity
Who cannot join
- Known pre-existing diabetes mellitus, based on patient report or medical record review
- A1C ≥ 6.5%, detected at study visit 1
- Use of medications known to affect glucose tolerance including corticosteroids, metformin, sulfonylureas, and others as determined by the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02118
About this study
It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To elucidate the pathophysiology underlying GDM, the investigators will attempt to discover these factors and characterize pregnancy-associated changes in insulin secretion and sensitivity in women with and without GDM.
Read the detailed description
Gestational diabetes mellitus (GDM) complicates 3-7% of pregnancies in the United States and is associated with perinatal morbidity and a high risk of future maternal type 2 diabetes. Current prevention and treatment of GDM relies on techniques developed in the type 2 diabetes population, without regard to unique physiology in pregnancy. GDM occurs in the setting of profound pregnancy changes in glucose metabolism: late pregnancy is normally characterized by marked insulin resistance. In order to maintain normal glucose levels and avoid GDM, pancreatic beta cells must augment insulin secretion to compensate. Women with GDM have inadequate beta-cell compensation for pregnancy-induced insulin resistance, resulting in hyperglycemia. It is unknown whether beta cell dysfunction and insulin resistance in GDM is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. Discovery of these factors and elucidation of the pathophysiology underlying GDM will allow for the development better GDM-specific prevention and treatment strategies.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Oral glucose tolerance test
- Keywords
- Insulin sensitivity, Insulin secretion, Pregnancy, Placental proteins
- 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.
Oral glucose tolerance testOther
Also called OGTT
75 gram oral glucose tolerance test (fasting) at: Visit 1 (pregnant [4-14 weeks gestation] and nonpregnant women); Visit 2 (pregnant subjects only at 24-28 weeks gestation); Visit 3 (pregnant subjects only at 6-12 weeks postpartum)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Pregnant women with history of GDM or at risk for diabetes mellitus will enter study during first trimester (4-14 weeks) and receive an oral glucose tolerance test (OGTT) at baseline, mid-pregnancy, and at delivery. Receives: Other: Oral glucose tolerance test | |
| Nonpregnant Women | Nonpregnant women with a history of GDM will undergo an OGTT at baseline. Receives: Other: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretory response
Insulin secretory response to a glucose load (insulinogenic index), adjusted for differences in insulin resistance, in pregnant women in the 1st trimester will be compared to the insulin secretory response in non-pregnant women
Measured: 1st trimester (gestational weeks 4-14)
Secondary outcomes (3)
Insulin secretory response
Insulin secretory response to a glucose load (insulinogenic index), adjusted for differences in insulin resistance, in pregnant women at 24-28 weeks gestation will be compared to the insulin secretory response in non-pregnant women
Measured: Mid-pregnancy (gestational weeks 24-28)
Change in insulin secretory response
Change in insulin secretory response to a glucose load (insulinogenic index) between 1st trimester and 24 to 28 weeks gestation, adjusted for changes in insulin resistance, in pregnant women who do and do not develop GDM
Measured: 1st trimester to 24-28 weeks gestation
Change in insulin secretory response
Change in insulin secretory response to a glucose load (insulinogenic index) between 1st trimester and postpartum, adjusted for changes in insulin resistance, in pregnant women who do and do not develop GDM
Measured: 1st trimester to postpartum (up to 12 weeks post-partum or up to 50 weeks after the first trimester visit, whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2021
- Study completionDec 2021
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.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camille Elise Powe,M.D., Massachusetts General Hospital
- Investigators
- Ravi I Thadhani, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763267
- Sponsor's protocol ID
- 2015P002447
- Acronym
- SPRING
- Status last verified
- May 2022
- First submitted
- 17 Feb 2016
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rosenberg EA, Seely EW, James K, Soffer MD, Nelson S, Nicklas JM, Powe CE. Carbohydrate Intake and Oral Glucose Tolerance Test Results in the Postpartum Period. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1007-e1012. doi: 10.1210/clinem/dgad234.
PubMed 37097924
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pregnancy Regulation of Insulin and Glucose
- ClinicalTrials.gov ID
- NCT02763267
- Acronym / sponsor ID
- SPRING / 2015P002447
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Insulin sensitivity, Insulin secretion, Pregnancy, Placental proteins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 5 May 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.
It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To elucidate the pathophysiology underlying GDM, the investigators will attempt to discover these factors and characterize pregnancy-associated changes in insulin secretion and sensitivity in women with and without GDM.
Detailed description
Gestational diabetes mellitus (GDM) complicates 3-7% of pregnancies in the United States and is associated with perinatal morbidity and a high risk of future maternal type 2 diabetes. Current prevention and treatment of GDM relies on techniques developed in the type 2 diabetes population, without regard to unique physiology in pregnancy. GDM occurs in the setting of profound pregnancy changes in glucose metabolism: late pregnancy is normally characterized by marked insulin resistance. In order to maintain normal glucose levels and avoid GDM, pancreatic beta cells must augment insulin secretion to compensate. Women with GDM have inadequate beta-cell compensation for pregnancy-induced insulin resistance, resulting in hyperglycemia. It is unknown whether beta cell dysfunction and insulin resistance in GDM is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. Undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of GDM. Discovery of these factors and elucidation of the pathophysiology underlying GDM will allow for the development better GDM-specific prevention and treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: Oral glucose tolerance testPregnant women with history of GDM or at risk for diabetes mellitus will enter study during first trimester (4-14 weeks) and receive an oral glucose tolerance test (OGTT) at baseline, mid-pregnancy, and at delivery. |
| Nonpregnant Women | – | Other: Oral glucose tolerance testNonpregnant women with a history of GDM will undergo an OGTT at baseline. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 150 Pregnant Women with history of GDM or at risk for diabetes mellitus and 200 Nonpregnant Women with history of GDM
Key inclusion criteria (10 listed)
- Women, age 18-44, non-pregnant OR in the 1st trimester of pregnancy (4-14 weeks gestation),
- Who had GDM in a previous pregnancy
- At risk for diabetes mellitus, as specified by the American Diabetes Association (ADA):
- BMI ≥ 25 kg/m2 (or BMI ≥ 23 kg/m2 if Asian-American) PLUS one or more of the following:
Key exclusion criteria (3 listed)
- Known pre-existing diabetes mellitus, based on patient report or medical record review
- A1C ≥ 6.5%, detected at study visit 1
- Use of medications known to affect glucose tolerance including corticosteroids, metformin, sulfonylureas, and others as determined by the investigators.
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 |
|---|---|---|
| Oral glucose tolerance testAlso: OGTT75 gram oral glucose tolerance test (fasting) at: Visit 1 (pregnant [4-14 weeks gestation] and nonpregnant women); Visit 2 (pregnant subjects only at 24-28 weeks gestation); Visit 3 (pregnant subjects only at 6-12 weeks postpartum) | Other | Nonpregnant Women, Pregnant Women |
Primary outcome
Insulin secretory response
Time frame: 1st trimester (gestational weeks 4-14)
Insulin secretory response to a glucose load (insulinogenic index), adjusted for differences in insulin resistance, in pregnant women in the 1st trimester will be compared to the insulin secretory response in non-pregnant women
3 secondary outcomes
Insulin secretory response
Time frame: Mid-pregnancy (gestational weeks 24-28)
Change in insulin secretory response
Time frame: 1st trimester to 24-28 weeks gestation
Change in insulin secretory response
Time frame: 1st trimester to postpartum (up to 12 weeks post-partum or up to 50 weeks after the first trimester visit, whichever comes first)
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 10 May 2022.
- Derived from this study: PubMed 37097924Rosenberg EA, Seely EW, James K, Soffer MD, Nelson S, Nicklas JM, Powe CE. Carbohydrate Intake and Oral Glucose Tolerance Test Results in the Postpartum Period. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1007-e1012. doi: 10.1210/clinem/dgad234.
- Individual participant dataSharing planned: Undecided
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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.
Ravi I Thadhani, MD, MPH principal investigator
Massachusetts General Hospital
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 Massachusetts General Hospital 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 10 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 10 May 2022. 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 secretory response (time frame: 1st trimester (gestational weeks 4-14)). 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 NCT02763267, 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 10 May 2022.