Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus (MATCh-GDM)
Primary Purpose
Gestational Diabetes, Diabetes, Gestational, Pregnancy in Diabetes
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin
Glyburide
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes focused on measuring Gestational diabetes, Diabetes in pregnancy, Insulin resistance, Insulin secretion deficiency
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
Sites / Locations
- Magee Womens Hospital of UPMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual Care
Individualized Treatment
Arm Description
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Outcomes
Primary Outcome Measures
Proportion of women who are eligible, screened, enroll and remain in the study
Proportion of participants who report suitability of the study procedures
Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview
Secondary Outcome Measures
Proportion of participants with consistent GDM mechanism before and and after treatment initiation
Proportion of women who remain on same treatment during study
Maternal glucose control
Proportion of participants who deliver by primary cesarean
Proportion of participants who developed hypertensive diseases in pregnancy
Birthweight
Neonatal lean body mass
Cord blood glucose
Cord blood c-peptide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03029702
Brief Title
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Acronym
MATCh-GDM
Official Title
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maisa N. Feghali, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Diabetes, Gestational, Pregnancy in Diabetes
Keywords
Gestational diabetes, Diabetes in pregnancy, Insulin resistance, Insulin secretion deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomized controlled study
Masking
Outcomes Assessor
Masking Description
Study team members assessing delivery outcomes will be masked to the participant's study assignment
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Arm Title
Individualized Treatment
Arm Type
Active Comparator
Arm Description
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin will be used for GDM treatment
Intervention Type
Drug
Intervention Name(s)
Glyburide
Intervention Description
Glyburide will be used for GDM treatment
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin will be used for GDM treatment
Primary Outcome Measure Information:
Title
Proportion of women who are eligible, screened, enroll and remain in the study
Time Frame
Through study completion, an average of 16 weeks
Title
Proportion of participants who report suitability of the study procedures
Description
Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview
Time Frame
Through study completion, an average of 16 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants with consistent GDM mechanism before and and after treatment initiation
Time Frame
2 weeks after treatment initiation
Title
Proportion of women who remain on same treatment during study
Time Frame
Through study completion, an average of 16 weeks
Title
Maternal glucose control
Time Frame
Delivery
Title
Proportion of participants who deliver by primary cesarean
Time Frame
Delivery
Title
Proportion of participants who developed hypertensive diseases in pregnancy
Time Frame
Delivery
Title
Birthweight
Time Frame
Delivery
Title
Neonatal lean body mass
Time Frame
Within 72 hours of delivery
Title
Cord blood glucose
Time Frame
Delivery
Title
Cord blood c-peptide
Time Frame
Delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maisa N Feghali, MD
Phone
4126414874
Email
feghalim@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maisa N Feghali, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD
Phone
412-641-4874
Email
feghalim@upmc.edu
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
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