Gestational DiabetesPhase 4MATCh-GDMNCT03029702
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
A Phase 4 study testing Insulin, Glyburide and Metformin in people with Gestational Diabetes and Diabetes, Gestational, run by Maisa N. Feghali, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Diabetes, Gestational, Pregnancy in Diabetes
- What is being tested?
- Insulin, Glyburide and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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).
- Keywords
- Gestational diabetes, Diabetes in pregnancy, Insulin resistance, Insulin secretion deficiency
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin will be used for GDM treatment
GlyburideDrug
Glyburide will be used for GDM treatment
MetforminDrug
Metformin will be used for GDM treatment
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin. Receives: Drug: Insulin; Drug: Glyburide; Drug: Metformin |
| Individualized Treatment | Active comparator | Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin. Receives: Drug: Insulin; Drug: Glyburide; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study
Proportion of women who are eligible, screened, enrolled and remain in the study
Measured: Through study completion, an average of 16 weeks
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
Measured: Through study completion, an average of 16 weeks
Secondary outcomes (9)
Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation
Measured: 2 weeks after treatment initiation
Proportion of Women Who Remain on Same Treatment During Study
Measured: Through study completion, an average of 16 weeks
Maternal Glucose Control
>50% fasting below 95 and 1 hour postprandial < 140 during the 4 weeks before delivery
Measured: Delivery
Proportion of Participants Who Deliver by Primary Cesarean
Measured: Delivery
Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy
Measured: Delivery
Birthweight
Measured: Delivery
Neonatal Lean Body Mass
Measured: Within 72 hours of delivery
Cord Blood Glucose
Measured: Delivery
Cord Blood C-peptide
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start28 Feb 2018
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisa N. Feghali, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Maisa N. Feghali, MD, University of Pittsburgh
- Investigators
- Maisa N Feghali, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029702
- Sponsor's protocol ID
- PRO16100499
- Other IDs
- K23HD092893
- Acronym
- MATCh-GDM
- Status last verified
- Nov 2024
- First submitted
- 19 Jan 2017
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03029702
- Acronym / sponsor ID
- MATCh-GDM / PRO16100499
- Keywords
- Gestational diabetes, Diabetes in pregnancy, Insulin resistance, Insulin secretion deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Maisa N. Feghali, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Drug: Insulin, Drug: Glyburide, Drug: MetforminParticipants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin. |
| Individualized Treatment | Active comparator | Drug: Insulin, Drug: Glyburide, Drug: MetforminParticipants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.
Key exclusion criteria (10 listed)
- Fetal anomaly
- Pregestational diabetes
- GDM diagnosis without a 3-hour OGTT
- Multifetal gestation
- Treatment with non-inhaled steroids within 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinInsulin will be used for GDM treatment | Drug | Individualized Treatment, Usual Care |
| GlyburideGlyburide will be used for GDM treatment | Drug | Individualized Treatment, Usual Care |
| MetforminMetformin will be used for GDM treatment | Drug | Individualized Treatment, Usual Care |
Primary outcome
Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study
Time frame: Through study completion, an average of 16 weeks
Proportion of women who are eligible, screened, enrolled and remain in the study
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
9 secondary outcomes
Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation
Time frame: 2 weeks after treatment initiation
Proportion of Women Who Remain on Same Treatment During Study
Time frame: Through study completion, an average of 16 weeks
Maternal Glucose Control
Time frame: Delivery
Proportion of Participants Who Deliver by Primary Cesarean
Time frame: Delivery
Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy
Time frame: Delivery
Birthweight
Time frame: Delivery
Neonatal Lean Body Mass
Time frame: Within 72 hours of delivery
Cord Blood Glucose
Time frame: Delivery
Cord Blood C-peptide
Time frame: Delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maisa N Feghali, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin, Glyburide and Metformin in people with Gestational Diabetes and Diabetes, Gestational, run by Maisa N. Feghali, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study (time frame: Through study completion, an average of 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.