Study of Pregnancy Regulation of Insulin and Glucose

NCT ID: NCT02763267

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 234 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Oral glucose tolerance test

Intervention Type: OTHER

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)

Nonpregnant Women

Nonpregnant women with a history of GDM will undergo an OGTT at baseline.

Oral glucose tolerance test

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

OGTT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Camille Elise Powe,M.D.

Co-Director, MGH Diabetes in Pregnancy Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ravi I Thadhani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37097924 (View on PubMed)

Other Identifiers

2015P002447

Identifier Type: -

Identifier Source: org_study_id