Early Screening and Treatment of Women With Prediabetes in Pregnancy

NCT01552213 | Completed Results

• 1 other identifier: 23445
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and diabetes in this country even among young women and the adverse affects of diabetes of pregnant women and their infants, the investigators feel that it is important to not only identify women at high risk for diabetes early in pregnancy but determine the appropriate management strategy

Conditions

Diabetes; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation.

  Diagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153)

  26 weeks of gestation

Secondary Outcomes (14)

• Number of Participants With Different Modes of Delivery

  Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation

• Number of Participants With Excessive Gestational Weight Gain

  Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation

• Mean Hemoglobin A1C Value at Delivery

  Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation

• Mean Fasting Triglyceride Level

  Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation

• Number of Patients With Gestational Hypertension

  Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation

Study Arms (2)

Treatment for glucose intolerance

ACTIVE COMPARATOR

Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.

Other: Treatment for glucose intolerance

Minimum intervention control group

ACTIVE COMPARATOR

Single visit with dietician or health educator followed by routine care per provider.

Other: Minimum intervention control group

Interventions

Minimum intervention control group OTHER

A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.

Minimum intervention control group

Treatment for glucose intolerance OTHER

Diet, exercise glucose monitoring, insulin if necessary

Treatment for glucose intolerance

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 or older
• Singleton pregnancy
• Prenatal care established at less than 14 weeks
• A1C 5.7-6.4%
• Delivery planned at Lucille Packard Children's Hospital at Stanford University (LPCH) or Santa Clara Valley Medical Center (SVMC)

You may not qualify if:

• preexisting diabetes or chronic steroid use
• known major fetal anomalies

Sponsors & Collaborators

• Stanford University: lead
• Santa Clara Valley Medical Center: collaborator

Study Sites (2)

Santa Clara Valley Medical Center

San Jose, California, 95108, United States

Location

Stanford University School of Medicine/Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Anna Girsen, Research Operations Manager
• Organization: Stanford University, School of Medicine

agirsen@stanford.edu

(650) 725-5720

Study Officials

• Yasser Y El-Sayed, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: Professor of Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-07

Locations

US (2)