Clinical trial NCT03029702: Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Official title: Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gestational Diabetes
Diabetes, Gestational
Pregnancy in Diabetes
Keywords: Gestational diabetes
Diabetes in pregnancy
Insulin resistance
Insulin secretion deficiency
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-01-24
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized controlled study
Primary purpose: TREATMENT

Brief summary: Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism).


Eligibility criteria: Inclusion Criteria:

* Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.

Exclusion Criteria:

* Fetal anomaly
* Pregestational diabetes
* GDM diagnosis without a 3-hour OGTT
* Multifetal gestation
* Treatment with non-inhaled steroids within 7 days
* Allergy to glyburide, metformin or sulfa
* History of severe pulmonary (pulmonary requirement for oxygen therapy or daily treatment for restrictive of obstructive pulmonary disease)
* Hepatic (LFT's greater than two times of upper normal range)
* Renal (serum creatinine higher than 1.2 mg/dL) disease
* History of heart failure or myocardial infarction

Primary outcomes:
measure: Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study
timeFrame: Through study completion, an average of 16 weeks
measure: Proportion of Participants Who Report Suitability of the Study Procedures
timeFrame: Through study completion, an average of 16 weeks
Secondary outcomes:
measure: Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation
timeFrame: 2 weeks after treatment initiation
measure: Proportion of Women Who Remain on Same Treatment During Study
timeFrame: Through study completion, an average of 16 weeks
measure: Maternal Glucose Control
timeFrame: Delivery
measure: Proportion of Participants Who Deliver by Primary Cesarean
timeFrame: Delivery
measure: Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy
timeFrame: Delivery
measure: Birthweight
timeFrame: Delivery
measure: Neonatal Lean Body Mass
timeFrame: Within 72 hours of delivery
measure: Cord Blood Glucose
timeFrame: Delivery
measure: Cord Blood C-peptide
timeFrame: Delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Maisa N Feghali, MD
role: PRINCIPAL_INVESTIGATOR
References: