Early Intervention for Gestational Diabetes

This study has been withdrawn prior to enrollment.
(Insufficient funding for enrollment of patients. The invesitgators realized the study could not be performed.)
Sponsor:
Information provided by (Responsible Party):
Ware Branch, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01171456
First received: July 13, 2010
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk of neonatal complications as well as an increased prevalence of a number of chronic diseases, including type 2 diabetes and schizophrenia. Recent research shows that treatment with metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective. Additional studies demonstrated that metformin is able to decrease the incidence of type 2 diabetes among individuals at risk for this disease. Based upon these findings, the investigators propose to test the hypothesis that metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.

The investigators intend to conduct a prospective, randomized, double-blind placebo controlled range-finding study to measure the effects of early metabolic intervention with metformin in women at risk for GDM before the commencement of pregnancy or prior to completion of the first trimester. The target sample size for this pilot study is 100 women. The effect size observed will provide preliminary data for a subsequent study which will be sufficiently powered to detect small or moderate effects from early metabolic intervention in women at risk for GDM.

The specific aims of the proposed research consist of the following:

  1. Determine whether treating women at risk for GDM with metformin prior to conception and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks' gestation.
  2. Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin in women at risk for GDM.
  3. Use these pilot study results to:

    1. identify specific demographic characteristics associated with an intervention effect
    2. calculate effect size for specific outcomes
    3. provide range-finding data for a subsequent study design

Metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.


Condition Intervention
Gestational Diabetes Mellitus
Drug: Metformin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Early Medical Intervention in Women at Risk for Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Effect of metformin versus placebo on the development of GDM [ Time Frame: Pre-conception to delivery (at 8 week intervals) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin. [ Time Frame: Pre-conception until discharge from hospital after delivery (at 4 week intervals) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Metformin Placebo Drug: Placebo
Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
Active Comparator: Metformin Drug: Metformin
Administration of Metformin or placebo prior to conception to prevent the onset of GDM.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women delivered >37 weeks gestation in the Intermountain Healthcare Urban Central Region within the last 18 months to ascertain those at risk for GDM in their next pregnancy because of:

  • A history of gestational diabetes in their immediately prior pregnancy
  • A family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
  • Delivery of an infant > 4000 gms.
  • B.M.I. > 30 six months postpartum
  • Hemoglobin A1C > 6.1% six months postpartum

Exclusion Criteria:

Pre-conception exclusion criteria will include any of the following:

  • History of >1 miscarriage or fetal demise
  • No contraindication to metformin (prior metformin intolerance, metabolic acidosis, GI disease)
  • Hypertension (BP >135/85)
  • No other endocrine, metabolic, renal, or autommune medical disorders
  • Prior preterm birth
  • Prior delivery complicated by shoulder dystocia
  • Prior delivery complicated by neonatal palsy
  • Multifetal pregnancy, including first-trimester embryonic demise of one or more
  • Uterine malformations
  • Illicit drug or alcohol abuse during current pregnancy
  • Intent to deliver elsewhere
  • Non-availability for prospective specimen/data collection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171456

Locations
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Ware Branch, M.D. Intermountain Health Care, Inc.
  More Information

No publications provided

Responsible Party: Ware Branch, Corporate Med. Director, Women and Newborns, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01171456     History of Changes
Other Study ID Numbers: 1017118
Study First Received: July 13, 2010
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
GDM
Gestational Diabetes
Diabetes
Pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014