NCT02530866

Brief Summary

This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

August 10, 2015

Last Update Submit

March 4, 2020

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in baseline maternal glycemia at 32-36 weeks gestation

    Women will undergo CGM for 5 days at both the first study visit (12-32 weeks) and again at the second study visit (32-36 weeks). Our primary outcome between women randomized to either SC or IT will compare mean 24-hour blood glucose levels as assessed by continuous glucose monitor at the 2nd study visit, which will occur between 32-36 weeks of gestation. Investigators hypothesize that women randomized to the IT group will have a 10 mg/dL lower mean 24-hour glucose as assessed by continuous glucose monitor when compared to women in the SC group. Investigators will also assess the prevalence of maternal hypoglycemia by comparing the amount of time with maternal blood glucose values \<60 mg/dL between groups.

    5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)

Secondary Outcomes (8)

  • Neonatal body composition

    At birth

  • Cytokine measurements

    20-30 weeks of gestation and 32-36 weeks of gestation

  • Physical activity

    9 months

  • Sleep assessments

    9 months

  • Patient questionnaires

    9 months

  • +3 more secondary outcomes

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Other: Lower glycemic targets

Intensive therapy

EXPERIMENTAL

Women in the arm will target fasting blood glucose values \<90 mg/dL and 1 hour post-prandial values \<120 mg/dL.

Other: Lower glycemic targets

Interventions

Lower glycemic targetsOTHER

Women will be randomized to either standard or lower glycemic targets.

Intensive therapyStandard care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • maternal age between 18-45 years
  • singleton birth
  • planned delivery at OU Medical Center
  • GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
  • one hour GCT \>200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
  • pre-pregnancy BMI ≥26 kg/m2.

You may not qualify if:

  • maternal tobacco use
  • planned delivery prior to 34 weeks of gestation
  • significant fetal anomalies
  • chronic hypertension requiring medication
  • other vascular disease
  • known renal disease with a baseline serum creatinine \>1.5 mg/dL
  • maternal rheumatologic disorders requiring medication
  • maternal human immunodeficiency virus (HIV) or hepatitis
  • as the specimen storage facility is not accredited to handle such samples
  • steroid use within 7 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (1)

  • Scifres CM, Mead-Harvey C, Nadeau H, Reid S, Pierce S, Feghali M, Myers D, Fields D, Stoner JA. Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. Am J Obstet Gynecol MFM. 2019 Nov;1(4):100050. doi: 10.1016/j.ajogmf.2019.100050. Epub 2019 Sep 27.

    PMID: 33345840DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Stephanie Pierce, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 21, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)