Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23HD092893 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Insulin will be used for GDM treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Through study completion, an average of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation | 2 weeks after treatment initiation | |
| Proportion of Women Who Remain on Same Treatment During Study | Through study completion, an average of 16 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maisa N Feghali, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin. Insulin: Insulin will be used for GDM treatment Glyburide: Glyburide will be used for GDM treatment Metformin: Metformin will be used for GDM treatment |
| FG001 | Individualized Treatment | Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin. Insulin: Insulin will be used for GDM treatment Glyburide: Glyburide will be used for GDM treatment Metformin: Metformin will be used for GDM treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin. Insulin: Insulin will be used for GDM treatment Glyburide: Glyburide will be used for GDM treatment Metformin: Metformin will be used for GDM treatment |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Through study completion, an average of 16 weeks |
|
Throughout study participation ~ 6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin. Insulin: Insulin will be used for GDM treatment Glyburide: Glyburide will be used for GDM treatment Metformin: Metformin will be used for GDM treatment |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maisa Feghali | University of Pittsburgh | 412 641 1000 | feghalim@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | Nov 6, 2024 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011254 | Pregnancy in Diabetics |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| D005905 | Glyburide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Pilot randomized controlled study
Not provided
Not provided
Study team members assessing delivery outcomes will be masked to the participant's study assignment
| Glyburide |
| Drug |
Glyburide will be used for GDM treatment |
|
| Metformin | Drug | Metformin will be used for GDM treatment |
|
| Maternal Glucose Control | >50% fasting below 95 and 1 hour postprandial < 140 during the 4 weeks before delivery | Delivery |
| Proportion of Participants Who Deliver by Primary Cesarean | Delivery |
| Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy | Delivery |
| Birthweight | Delivery |
| Neonatal Lean Body Mass | Within 72 hours of delivery |
| Cord Blood Glucose | Delivery |
| Cord Blood C-peptide | Delivery |
| Individualized Treatment |
Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin. Insulin: Insulin will be used for GDM treatment Glyburide: Glyburide will be used for GDM treatment Metformin: Metformin will be used for GDM treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Through study completion, an average of 16 weeks |
|
|
|
|
| Secondary | Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation | Posted | Count of Participants | Participants | 2 weeks after treatment initiation |
|
|
|
|
| Secondary | Proportion of Women Who Remain on Same Treatment During Study | Posted | Count of Participants | Participants | Through study completion, an average of 16 weeks |
|
|
|
|
| Secondary | Maternal Glucose Control | >50% fasting below 95 and 1 hour postprandial < 140 during the 4 weeks before delivery | Posted | Count of Participants | Participants | Delivery |
|
|
|
|
| Secondary | Proportion of Participants Who Deliver by Primary Cesarean | Posted | Count of Participants | Participants | Delivery |
|
|
|
|
| Secondary | Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy | Posted | Count of Participants | Participants | Delivery |
|
|
|
|
| Secondary | Birthweight | Posted | Mean | Standard Deviation | g | Delivery |
|
|
|
|
| Secondary | Neonatal Lean Body Mass | Unable to collect neonatal data due to lack of staffing availability | Posted | Within 72 hours of delivery |
|
|
| Secondary | Cord Blood Glucose | Samples unavailable for analysis due to freezer storage malfunction | Posted | Delivery |
|
|
| Secondary | Cord Blood C-peptide | Samples unavailable for analysis due to freezer storage malfunction | Posted | Delivery |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Individualized Treatment | Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin. Insulin: Insulin will be used for GDM treatment Glyburide: Glyburide will be used for GDM treatment Metformin: Metformin will be used for GDM treatment | 0 | 27 | 0 | 27 | 0 | 27 |
Not provided
Not provided
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |