Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

NCT03029702 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: PRO16100499K23HD092893
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes; Diabetes, Gestational; Pregnancy in Diabetes

Keywords

Gestational diabetes; Diabetes in pregnancy; Insulin resistance; Insulin secretion deficiency

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• 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

• Maternal Glucose Control

  Delivery

• Proportion of Participants Who Deliver by Primary Cesarean

  Delivery

• Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy

  Delivery

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

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.

Drug: Insulin; Drug: Glyburide; Drug: Metformin

Interventions

Insulin DRUG

Insulin will be used for GDM treatment

Individualized Treatment; Usual Care

Glyburide DRUG

Glyburide will be used for GDM treatment

Individualized Treatment; Usual Care

Metformin DRUG

Metformin will be used for GDM treatment

Individualized Treatment; Usual Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisa N. Feghali, MD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy in Diabetics; Insulin Resistance

Interventions

Insulin; Glyburide; Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Maisa Feghali
• Organization: University of Pittsburgh

feghalim@upmc.edu

412 641 1000

Study Officials

• Maisa N Feghali, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study team members assessing delivery outcomes will be masked to the participant's study assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot randomized controlled study

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 24, 2017
• Study Start: February 28, 2018
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)