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Search / Trial NCT06445270

Evidence-informed Trial of Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals

Launched by INDIANA UNIVERSITY · May 31, 2024

Trial Information

Current as of February 18, 2025

Not yet recruiting

Keywords

Gestational Diabetes Prevention Pregnancy Continuous Glucose Monitor

ClinConnect Summary

GDM is associated with adverse maternal and newborn outcomes, as well as potential lifelong consequences. Currently, clinical guidelines recommend screening for pre-existing Type 2 diabetes mellitus at new obstetric visits for individuals at high risk of developing GDM. For those who do not screen positive, but still may be at risk for GDM, standard practice is for basic diet, exercise, and weight gain counseling.

In this study, eligible participants will be randomized into one of two groups: usual care with standard diet and exercise counseling or a GDM prevention program that consists of...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Gestational age less or equal to 16 + 6 weeks confirmed via ACOG dating guidelines AND one of the following
  • 35 years of age or older
  • Family history of first degree relative with diabetes mellitus
  • Body Mass Index (BMI) greater than or equal to 30
  • Hemoglobin A1c value between 5.9% to 6.4%
  • Exclusion Criteria:
  • Multiple gestations
  • Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy
  • Pre-pregnancy chronic (\>2 weeks) usage of systemic steroids (inhaled and short term usage acceptable)
  • Planned pregnancy termination
  • Currently taking or took 3 months prior to conception Metformin
  • Unable to provide informed consent in English or Spanish
  • Major fetal anomalies listed below that are known prior to enrollment.
  • Major fetal anomalies:
  • Congenital diaphragmatic hernia
  • Congenital cystic adenomatoid malformation
  • Pleural effustions
  • Chylothorax
  • Bronchogenic cyst
  • Bronchopulmonary sequestration
  • Anomalous pulmonary venous return
  • Tricuspid atresia
  • Mitral atresia
  • Double right ventricle
  • Ebstein's malformation
  • Pulmonary atresia
  • Hypoplastic left heart syndrome
  • Aortic coarctation
  • Fetal arrhythmias
  • Transposition of the great vessels
  • Tetrology of Fallot
  • Double outlet right ventricle
  • Aortic stenosis
  • Holoprosencephaly
  • Anencephaly
  • Dandy-Walker malformation or variant
  • Septo-optic dysplasia
  • Neural tube defect
  • Vein of Galen aneurysm
  • Bilateral renal agenesis
  • Cystic renal disease
  • Obstructive uropathy
  • Horseshoe kidney
  • Megacystis microcolon
  • Cloacal abnormality
  • Achondrogenesis
  • Thanatophoric dysplasia
  • Thoracic dysplasia
  • Osteogenesis imperfecta
  • Short rib polydacyly
  • Any skeletal defect with suspected small thorax
  • Hypophosphatemia
  • Any karyotypic abnormality
  • Any suspected genetic syndrome
  • Cleft lip/palate
  • Micrognathia
  • Hydrops
  • Fetal anemia (\<35% on cordocentesis)
  • Neck mass
  • Gastroschsis
  • Omphalocele

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0