Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

NCT05124808 | Recruiting DMC

• 2 other identifiers: 11435R01HD101476
• Study Type: interventional
• Target: 828
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.

Conditions

Gestational Diabetes; Pregnancy, High Risk; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Number of participants with composite neonatal morbidity

  Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome

  Within 7 days of delivery

Secondary Outcomes (17)

• Number of participants with large for gestational age birth weight

  Birth

• Number of participants with neonatal hypoglycemia

  Within 24 hours of delivery

• Number of participants with neonatal jaundice

  Within 7 days of delivery

• Number of participants with respiratory distress syndrome

  Within 7 days of delivery

• Maternal hyperglycemia

  From randomization to delivery

Study Arms (2)

Intensive glycemic targets

EXPERIMENTAL

Participants in this arm will target a fasting blood glucose of \<90 mg/dL and 1 hour post-prandial blood glucose values \<120 mg/dL.

Other: Intensive glycemic targets

Standard glycemic targets

ACTIVE COMPARATOR

Participants in this arm will target a fasting blood glucose of \<95 mg/dL and 1 hour post-prandial blood glucose values \<140 mg/dL.

Other: Standard glycemic targets

Interventions

Intensive glycemic targets OTHER

Fasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL

Intensive glycemic targets

Standard glycemic targets OTHER

Fasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL

Standard glycemic targets

Eligibility Criteria

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

You may qualify if:

• Pregnant women between the ages of 18-45
• Singleton gestation
• Gestational age between 12 0/7-32 6/7 weeks' gestation with gestational diabetes diagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg/dL or two or more abnormal values on a 100g OGTT using the Carpenter-Coustan Criteria
• Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)

You may not qualify if:

• Inability or unwillingness to provide informed consent
• Inability to communicate with members of the study team, despite the presence of an interpreter
• Planned delivery at a non-study affiliated hospital
• Known renal disease with a baseline creatinine \>1.5 mg/dL
• Significant fetal anomalies diagnosed prior to study enrollment (these will include anomalies such as gastroschisis, spina bifida, complex congenital heart disease, or serious karyotypic anomalies that may lead to early delivery or increased risk of neonatal death)
• Oral or IV/IM steroid use within 7 days of study enrollment

Sponsors & Collaborators

• Indiana University: lead
• University of Pittsburgh: collaborator
• University of Alabama at Birmingham: collaborator
• University of Oklahoma: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Oklahoma

Norman, Oklahoma, 73019, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (1)

• Scifres CM, Battarbee AN, Feghali MN, Pierce S, Edwards RK, Smith EM, Guise D, Bhamidipalli S, Daggy J, Tuuli MG. Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study. BMJ Open. 2024 Feb 29;14(2):e082126. doi: 10.1136/bmjopen-2023-082126.

  PMID: 38423770 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Overweight; Obesity

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; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina Scifres, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Oswalt

CONTACT

(317)944-7069; seoswalt@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 18, 2021
• Study Start: March 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 8, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available one year after study completion.
• Access Criteria: Data access will be possible after approval of the request for data by the primary study team and after appropriate regulatory documents are in place.

Locations

US (5)