Trial record 8 of 92 for:    Open Studies | "Prediabetic State"

Treating Prediabetes in the First Trimester

This study is currently recruiting participants.
Verified August 2013 by University of California, San Diego
Sponsor:
Collaborators:
American Association of Obstetricians and Gynecologists Foundation (AAOGF)
Society for Maternal-Fetal Medicine Pregnancy Foundation
Information provided by (Responsible Party):
Hilary Roeder, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01926457
First received: August 15, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

The investigators plan to study a sample of women with prediabetes (diagnosed by Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL) in the first trimester of pregnancy, and patients will be randomized to first trimester or third trimester treatment; the first trimester group will receive intervention immediately upon diagnosis of prediabetes whereas the third trimester group will receive only routine prenatal care until 28 weeks at which time they will receive intervention.

Intervention is defined as:

  • diabetes education
  • blood glucose monitoring
  • medications as needed
  • growth ultrasounds
  • antenatal testing

The primary outcome is umbilical cord C-Peptide >90th percentile. Secondary outcomes include neonatal fat mass at delivery, infant weight-for-length at 12 months of age, maternal gestational weight gain, and biomarkers (chemicals) measured in the placenta and the baby's umbilical cord blood.

The investigators hypothesize that women who undergo the above intervention in the first trimester will deliver significantly fewer neonates with umbilical cord C-Peptide >90th percentile, and that the neonates will have lower fat mass, and weight-for-length at 12 months. The investigators further hypothesize that a greater proportion of patients undergoing first trimester intervention will have appropriate maternal gestational weight gain as defined by the Institute of Medicine, and a greater proportion will return to prepregnancy weight within 12 months. Finally, in this first trimester cohort, the investigators expect higher placental levels of Sirtuin-1 (SirT-1), higher levels of adiponectin in maternal blood and lower adiponectin in cord blood.


Condition Intervention
Prediabetes
Gestational Diabetes
Other: Treatment of Prediabetes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Treating Prediabetes in the First Trimester: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Umbilical Cord C-Peptide >90th percentile [ Time Frame: 1 day (Collected at the time of delivery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neonatal fat mass [ Time Frame: Within 48 hours of delivery ] [ Designated as safety issue: No ]
    Neonatal fat mass will be measured using an anthropometric model using weight, length, and flank skinfold thickness.

  • Adherence to the Institute of Medicine (IOM) guidelines for gestational weight gain [ Time Frame: Weight gain will be measured from immediately preconception until delivery ] [ Designated as safety issue: No ]
    The IOM recommends that underweight women (BMI<18.5kg/m2) gain 28-40lbs, normal women (BMI 18.5-24.9 kg/m2) gain 25-35lbs, overweight women (BMI 25.0-29.9 kg/m2) gain 15-25lbs and obese women (BMI≥30 kg/m2) gain 11-20 lbs.

  • Return to prepregnancy weight [ Time Frame: After 1 year post delivery ] [ Designated as safety issue: No ]
  • Placental SirT-1 [ Time Frame: 1 day (Collected at the time of delivery) ] [ Designated as safety issue: No ]
  • Maternal adiponectin [ Time Frame: Within 24 hours of delivery ] [ Designated as safety issue: No ]
  • Umbilical cord blood adiponectin [ Time Frame: 1 day (Collected at the time of delivery) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • birthweight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • birthweight percentile [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Infant gender [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Ponderal index [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Weight/length^3

  • Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: Within 10 days after birth ] [ Designated as safety issue: No ]
  • Infant weight-for-length [ Time Frame: 6 weeks, 6 months, 9 months, and 12 months after delivery ] [ Designated as safety issue: No ]
  • Need for pharmacotherapy to control hyperglycemia [ Time Frame: From 5 weeks gestation until time of delivery ] [ Designated as safety issue: No ]
  • Birth trauma [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Shoulder dystocia, brachial plexus injury

  • Mode of delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Spontaneous delivery, operative vaginal delivery, cesarean delivery

  • Indication for delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Total gestational weight gain [ Time Frame: From immediately preconception until delivery ] [ Designated as safety issue: No ]
  • Postpartum weight retention [ Time Frame: Within 1 year of delivery ] [ Designated as safety issue: No ]
  • Diagnosis of Preeclampsia [ Time Frame: From 20 weeks gestation until 6 weeks postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Trimester Treatment of Prediabetes

Patients randomized to first trimester treatment will receive the following intervention immediately initiated upon diagnosis of prediabetes at <15 weeks 0 days gestation

  • diabetes education
  • blood glucose monitoring
  • medications as needed per California Diabetes and Pregnancy established protocol
  • growth ultrasounds
  • antenatal testing
Other: Treatment of Prediabetes

Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"

  • diabetes education
  • blood glucose monitoring
  • medications as needed per California Diabetes and Pregnancy established protocol
  • growth ultrasounds
  • antenatal testing
Active Comparator: Third Trimester Treatment of Prediabetes

Patients randomized to third trimester treatment will receive the following intervention to be initiated at 28 weeks of gestation

  • diabetes education
  • blood glucose monitoring
  • medications as needed per California Diabetes and Pregnancy established protocol
  • growth ultrasounds
  • antenatal testing
Other: Treatment of Prediabetes

Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"

  • diabetes education
  • blood glucose monitoring
  • medications as needed per California Diabetes and Pregnancy established protocol
  • growth ultrasounds
  • antenatal testing

Detailed Description:

The primary aim of the proposed research is to demonstrate that promoting a normoglycemic intrauterine milieu in women with prediabetes diagnosed in the first trimester of pregnancy with a Hemoglobin A1c (HbA1c) 5.7-6.4% or fasting plasma glucose (FPG) 92-125 mg/dL will decrease the accumulation of fetal white adipose tissue and development of infant/child obesity during the first year of life. This project is built upon the hypothesis that pregnant subjects with prediabetes randomized in the first trimester of pregnancy to strict glycemic control and pharmacotherapy as needed will have less fetal adiposity and adverse neonatal outcomes than those who receive the diagnosis of prediabetes but do not initiate care until the third trimester.

In the proposed study, 240 women meeting the above criteria for prediabetes at ≤ 15w0d gestation will be randomized to either first trimester or third trimester treatment. Each group will have diabetes education, initiate blood glucose monitoring, begin pharmacotherapy as needed (per established protocol), undergo growth ultrasounds, and antenatal testing. The first trimester arm will receive the above interventions immediately upon diagnosis of prediabetes whereas the third trimester arm will receive only routine prenatal care until 28 weeks at which time they will begin education and treatment. Both groups will be treated identically from 28 weeks until delivery.

In the 2013 the National Institutes of Health (NIH) Gestational Diabetes (GDM) Consensus Conference, the panel was concerned about adopting criteria that would increase prevalence of GDM (i.e. first trimester treatment) without first demonstrating improved outcomes. The results of this proposed trial, will allow us to fill key research gaps; this is the first prospective trial to evaluate the International Associations of Diabetes in Pregnancy Study Groups (IADPSG) recommendations for screening and diagnosing prediabetes in the first trimester.

Findings from this research will quantify the maternal and neonatal benefits and harms of treating women with prediabetes from early pregnancy. Additionally, the cohort of neonates that will result from this study can be followed into childhood to evaluate whether first trimester treatment has benefits beyond those anticipated at birth and may decrease the long-term incidence of obesity and diabetes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women age 18 and above
  • Any ethnic background
  • English- or Spanish-speaking
  • Planned prenatal care/delivery at The University of California, San Diego's Hillcrest Hospital
  • Singleton pregnancy
  • Prediabetes diagnosed prior to 15w0d with HbA1c 5.7-6.4% or FPG 92-125 mg/dL

Exclusion Criteria:

  • Known Type 2 Diabetes (T2DM)
  • T2DM diagnosed with first trimester screening
  • Patients with known maternal/fetal indications for delivery <36w0d
  • Patients presenting for care after 15w0d
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01926457

Contacts
Contact: Hilary A Roeder, MD 619-543-2384 haroeder@ucsd.edu
Contact: Gladys A Ramos, MD 619-543-2384 gramos@ucsd.edu

Locations
United States, California
UC San Diego Health System Recruiting
San Diego, California, United States, 92103
Contact: Hilary A Roeder, MD    619-543-2384    haroeder@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
American Association of Obstetricians and Gynecologists Foundation (AAOGF)
Society for Maternal-Fetal Medicine Pregnancy Foundation
Investigators
Principal Investigator: Hilary A Roeder, MD UC San Diego Health System
Principal Investigator: Gladys A Ramos, MD UC San Diego Health System
Principal Investigator: Thomas R Moore, MD UC San Diego Health System
  More Information

Additional Information:
Publications:

Responsible Party: Hilary Roeder, MD, Physican, Clinical Instructor, Maternal-Fetal Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01926457     History of Changes
Other Study ID Numbers: UCSD-GDM-RCT
Study First Received: August 15, 2013
Last Updated: August 20, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of California, San Diego:
First trimester treatment of prediabetes
First trimester treatment of gestational diabetes
Umbilical cord C-Peptide
Neonatal fat mass
Gestational weight gain
Infant obesity
SirT-1
Adiponectin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Hyperglycemia

ClinicalTrials.gov processed this record on April 17, 2014