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Study of Pregnancy Regulation of Insulin and Glucose (SPRING)

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ClinicalTrials.gov Identifier: NCT02763267
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Camille Elise Powe,M.D., Massachusetts General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Gestational Diabetes Mellitus Other: Oral glucose tolerance test

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.

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Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Pregnancy Regulation of Insulin and Glucose
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 2021
Actual Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
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.
Other: Oral glucose tolerance test
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)
Other Name: OGTT

Nonpregnant Women
Nonpregnant women with a history of GDM will undergo an OGTT at baseline.
Other: Oral glucose tolerance test
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)
Other Name: OGTT




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Insulin secretory response [ Time Frame: Mid-pregnancy (gestational weeks 24-28) ]
    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

  2. Change in insulin secretory response [ Time Frame: 1st trimester to 24-28 weeks gestation ]
    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

  3. 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) ]
    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


Biospecimen Retention:   Samples With DNA
Blood, urine, DNA, plasma, serum. With subject consent: maternal cord blood, urine, DNA, fetal cord blood, neonatal DNA, placental tissue, RNA


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 Pregnant Women with history of GDM or at risk for diabetes mellitus and 200 Nonpregnant Women with history of GDM
Criteria

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763267


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ravi I Thadhani, MD, MPH Massachusetts General Hospital
Additional Information:
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Responsible Party: Camille Elise Powe,M.D., Co-Director, MGH Diabetes in Pregnancy Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02763267    
Other Study ID Numbers: 2015P002447
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Camille Elise Powe,M.D., Massachusetts General Hospital:
Insulin sensitivity
Insulin secretion
Pregnancy
Placental proteins
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases