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Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus (MATCh-GDM)

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ClinicalTrials.gov Identifier: NCT03029702
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Maisa Feghali, University of Pittsburgh

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).

Condition or disease Intervention/treatment Phase
Gestational Diabetes Diabetes, Gestational Pregnancy in Diabetes Drug: Insulin Drug: Glyburide Drug: Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot randomized controlled study
Masking: Single (Outcomes Assessor)
Masking Description: Study team members assessing delivery outcomes will be masked to the participant's study assignment
Primary Purpose: Treatment
Official Title: Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care
Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
Drug: Insulin
Insulin will be used for GDM treatment

Drug: Glyburide
Glyburide will be used for GDM treatment

Drug: Metformin
Metformin will be used for GDM treatment

Active Comparator: Individualized Treatment
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
Drug: Insulin
Insulin will be used for GDM treatment

Drug: Glyburide
Glyburide will be used for GDM treatment

Drug: Metformin
Metformin will be used for GDM treatment




Primary Outcome Measures :
  1. Proportion of women who are eligible, screened, enroll and remain in the study [ Time Frame: Through study completion, an average of 16 weeks ]
  2. Proportion of participants who report suitability of the study procedures [ Time Frame: Through study completion, an average of 16 weeks ]
    Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview


Secondary Outcome Measures :
  1. Proportion of participants with consistent GDM mechanism before and and after treatment initiation [ Time Frame: 2 weeks after treatment initiation ]
  2. Proportion of women who remain on same treatment during study [ Time Frame: Through study completion, an average of 16 weeks ]
  3. Maternal glucose control [ Time Frame: Delivery ]
  4. Proportion of participants who deliver by primary cesarean [ Time Frame: Delivery ]
  5. Proportion of participants who developed hypertensive diseases in pregnancy [ Time Frame: Delivery ]
  6. Birthweight [ Time Frame: Delivery ]
  7. Neonatal lean body mass [ Time Frame: Within 72 hours of delivery ]
  8. Cord blood glucose [ Time Frame: Delivery ]
  9. Cord blood c-peptide [ Time Frame: Delivery ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029702


Contacts
Contact: Maisa N Feghali, MD 4126414874 feghalim@upmc.edu

Locations
United States, Pennsylvania
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Maisa Feghali, MD    412-641-4874    feghalim@upmc.edu   
Principal Investigator: Maisa Feghali, MD         
Sponsors and Collaborators
Maisa Feghali
Investigators
Principal Investigator: Maisa N Feghali, MD University of Pittsburgh

Responsible Party: Maisa Feghali, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03029702     History of Changes
Other Study ID Numbers: PRO16100499
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Maisa Feghali, University of Pittsburgh:
Gestational diabetes
Diabetes in pregnancy
Insulin resistance
Insulin secretion deficiency

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs