Study of Pregnancy Regulation of Insulin and Glucose

NCT02763267 | Completed

• 1 other identifier: 2015P002447
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Insulin sensitivity; Insulin secretion; Pregnancy; Placental proteins

Outcome Measures

Primary Outcomes (1)

• 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

  1st trimester (gestational weeks 4-14)

Secondary Outcomes (3)

• Insulin secretory response

  Mid-pregnancy (gestational weeks 24-28)

• Change in insulin secretory response

  1st trimester to 24-28 weeks gestation

• Change in insulin secretory response

  1st trimester to postpartum (up to 12 weeks post-partum or up to 50 weeks after the first trimester visit, whichever comes first)

Study Arms (2)

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

Nonpregnant Women

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

Other: Oral glucose tolerance test

Interventions

Oral glucose tolerance test 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)

Also known as: OGTT

Nonpregnant Women; Pregnant Women

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 37097924 DERIVED

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

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Ravi I Thadhani, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, MGH Diabetes in Pregnancy Program

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: May 5, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (1)