- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01926457
Treating Prediabetes in the First Trimester
Treating Prediabetes in the First Trimester: A Randomized Controlled Trial
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
San Diego, California, États-Unis, 92103
- UC San Diego Health System
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
|
Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"
|
Comparateur actif: Third Trimester Treatment of Prediabetes
Patients randomized to third trimester treatment will receive the following intervention to be initiated at 28 weeks of gestation
|
Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Umbilical Cord C-Peptide >90th percentile
Délai: 1 day (Collected at the time of delivery)
|
1 day (Collected at the time of delivery)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Neonatal fat mass
Délai: Within 48 hours of delivery
|
Neonatal fat mass will be measured using an anthropometric model using weight, length, and flank skinfold thickness.
|
Within 48 hours of delivery
|
Adherence to the Institute of Medicine (IOM) guidelines for gestational weight gain
Délai: Weight gain will be measured from immediately preconception until delivery
|
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.
|
Weight gain will be measured from immediately preconception until delivery
|
Return to prepregnancy weight
Délai: After 1 year post delivery
|
After 1 year post delivery
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
birthweight
Délai: At delivery
|
At delivery
|
|
birthweight percentile
Délai: At delivery
|
At delivery
|
|
Infant gender
Délai: At delivery
|
At delivery
|
|
Ponderal index
Délai: At delivery
|
Weight/length^3
|
At delivery
|
Neonatal Intensive Care Unit (NICU) Admission
Délai: Within 10 days after birth
|
Within 10 days after birth
|
|
Infant weight-for-length
Délai: 6 months and 12 months after delivery
|
6 months and 12 months after delivery
|
|
Need for pharmacotherapy to control hyperglycemia
Délai: From 5 weeks gestation until time of delivery
|
From 5 weeks gestation until time of delivery
|
|
Birth trauma
Délai: At delivery
|
Shoulder dystocia, brachial plexus injury
|
At delivery
|
Mode of delivery
Délai: At delivery
|
Spontaneous delivery, operative vaginal delivery, cesarean delivery
|
At delivery
|
Indication for delivery
Délai: At delivery
|
At delivery
|
|
Total gestational weight gain
Délai: From immediately preconception until delivery
|
From immediately preconception until delivery
|
|
Postpartum weight retention
Délai: Within 1 year of delivery
|
Within 1 year of delivery
|
|
Diagnosis of Preeclampsia
Délai: From 20 weeks gestation until 6 weeks postpartum
|
From 20 weeks gestation until 6 weeks postpartum
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hilary A Roeder, MD, UC San Diego Health System
- Chercheur principal: Gladys A Ramos, MD, UC San Diego Health System
- Chercheur principal: Thomas R Moore, MD, UC San Diego Health System
Publications et liens utiles
Publications générales
- Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
- Catalano PM, Thomas AJ, Avallone DA, Amini SB. Anthropometric estimation of neonatal body composition. Am J Obstet Gynecol. 1995 Oct;173(4):1176-81. doi: 10.1016/0002-9378(95)91348-3.
- Catalano PM, Thomas A, Huston-Presley L, Amini SB. Increased fetal adiposity: a very sensitive marker of abnormal in utero development. Am J Obstet Gynecol. 2003 Dec;189(6):1698-704. doi: 10.1016/s0002-9378(03)00828-7.
- HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Kim SY, Sharma AJ, Callaghan WM. Gestational diabetes and childhood obesity: what is the link? Curr Opin Obstet Gynecol. 2012 Dec;24(6):376-81. doi: 10.1097/GCO.0b013e328359f0f4.
- International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
- HAPO Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes. 2009 Feb;58(2):453-9. doi: 10.2337/db08-1112. Epub 2008 Nov 14.
- Hedderson MM, Gunderson EP, Ferrara A. Gestational weight gain and risk of gestational diabetes mellitus. Obstet Gynecol. 2010 Mar;115(3):597-604. doi: 10.1097/AOG.0b013e3181cfce4f. Erratum In: Obstet Gynecol. 2010 May;115(5):1092.
- Riskin-Mashiah S, Younes G, Damti A, Auslender R. First-trimester fasting hyperglycemia and adverse pregnancy outcomes. Diabetes Care. 2009 Sep;32(9):1639-43. doi: 10.2337/dc09-0688. Epub 2009 Jun 23.
- Persson B, Heding LG, Lunell NO, Pschera H, Stangenberg M, Wager J. Fetal beta cell function in diabetic pregnancy. Amniotic fluid concentrations of proinsulin, insulin, and C-peptide during the last trimester of pregnancy. Am J Obstet Gynecol. 1982 Oct 15;144(4):455-9.
- Lappas M, Andrikopoulos S, Permezel M. Hypoxanthine-xanthine oxidase down-regulates GLUT1 transcription via SIRT1 resulting in decreased glucose uptake in human placenta. J Endocrinol. 2012 Apr;213(1):49-57. doi: 10.1530/JOE-11-0355. Epub 2012 Jan 19.
- Gillum MP, Kotas ME, Erion DM, Kursawe R, Chatterjee P, Nead KT, Muise ES, Hsiao JJ, Frederick DW, Yonemitsu S, Banks AS, Qiang L, Bhanot S, Olefsky JM, Sears DD, Caprio S, Shulman GI. SirT1 regulates adipose tissue inflammation. Diabetes. 2011 Dec;60(12):3235-45. doi: 10.2337/db11-0616.
- Banks AS, Kon N, Knight C, Matsumoto M, Gutierrez-Juarez R, Rossetti L, Gu W, Accili D. SirT1 gain of function increases energy efficiency and prevents diabetes in mice. Cell Metab. 2008 Oct;8(4):333-41. doi: 10.1016/j.cmet.2008.08.014.
- Astapova O, Leff T. Adiponectin and PPARgamma: cooperative and interdependent actions of two key regulators of metabolism. Vitam Horm. 2012;90:143-62. doi: 10.1016/B978-0-12-398313-8.00006-3.
- Qiao L, Yoo HS, Madon A, Kinney B, Hay WW Jr, Shao J. Adiponectin enhances mouse fetal fat deposition. Diabetes. 2012 Dec;61(12):3199-207. doi: 10.2337/db12-0055. Epub 2012 Aug 7.
- Luo ZC, Nuyt AM, Delvin E, Fraser WD, Julien P, Audibert F, Girard I, Shatenstein B, Deal C, Grenier E, Garofalo C, Levy E. Maternal and fetal leptin, adiponectin levels and associations with fetal insulin sensitivity. Obesity (Silver Spring). 2013 Jan;21(1):210-6. doi: 10.1002/oby.20250.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UCSD-GDM-RCT
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