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Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

NCT ID: NCT03029702

Last Updated: 2024-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2023-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Gestational Diabetes Diabetes, Gestational Pregnancy in Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Study team members assessing delivery outcomes will be masked to the participant's study assignment

Study Groups

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Usual Care

Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin will be used for GDM treatment

Glyburide

Intervention Type DRUG

Glyburide will be used for GDM treatment

Metformin

Intervention Type DRUG

Metformin will be used for GDM treatment

Individualized Treatment

Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin will be used for GDM treatment

Glyburide

Intervention Type DRUG

Glyburide will be used for GDM treatment

Metformin

Intervention Type DRUG

Metformin will be used for GDM treatment

Interventions

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Insulin

Insulin will be used for GDM treatment

Intervention Type DRUG

Glyburide

Glyburide will be used for GDM treatment

Intervention Type DRUG

Metformin

Metformin will be used for GDM treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Maisa N. Feghali, MD

OTHER

Sponsor Role lead

Responsible Party

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Maisa N. Feghali, MD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Maisa N Feghali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K23HD092893

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO16100499

Identifier Type: -

Identifier Source: org_study_id