Intensive Management for Gestational Diabetes

NCT ID: NCT02530866

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-03-31

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.

Detailed Description

The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy.

In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

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

Group Type: ACTIVE_COMPARATOR

Lower glycemic targets

Intervention Type: OTHER

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

Intensive therapy

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

Group Type: EXPERIMENTAL

Lower glycemic targets

Intervention Type: OTHER

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

Interventions

Lower glycemic targets

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Pierce, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33345840 (View on PubMed)

Other Identifiers

5446

Identifier Type: -

Identifier Source: org_study_id