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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Diego、California、アメリカ、92103
- UC San Diego Health System
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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
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Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"
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アクティブコンパレータ:Third Trimester Treatment of Prediabetes
Patients randomized to third trimester treatment will receive the following intervention to be initiated at 28 weeks of gestation
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Standardized treatment of prediabetes per California Diabetes and Pregnancy Program "Sweet Success"
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Umbilical Cord C-Peptide >90th percentile
時間枠:1 day (Collected at the time of delivery)
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1 day (Collected at the time of delivery)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Neonatal fat mass
時間枠:Within 48 hours of delivery
|
Neonatal fat mass will be measured using an anthropometric model using weight, length, and flank skinfold thickness.
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Within 48 hours of delivery
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Adherence to the Institute of Medicine (IOM) guidelines for gestational weight gain
時間枠:Weight gain will be measured from immediately preconception until delivery
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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
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Return to prepregnancy weight
時間枠:After 1 year post delivery
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After 1 year post delivery
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
birthweight
時間枠:At delivery
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At delivery
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birthweight percentile
時間枠:At delivery
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At delivery
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Infant gender
時間枠:At delivery
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At delivery
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Ponderal index
時間枠:At delivery
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Weight/length^3
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At delivery
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Neonatal Intensive Care Unit (NICU) Admission
時間枠:Within 10 days after birth
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Within 10 days after birth
|
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Infant weight-for-length
時間枠:6 months and 12 months after delivery
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6 months and 12 months after delivery
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Need for pharmacotherapy to control hyperglycemia
時間枠:From 5 weeks gestation until time of delivery
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From 5 weeks gestation until time of delivery
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Birth trauma
時間枠:At delivery
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Shoulder dystocia, brachial plexus injury
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At delivery
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Mode of delivery
時間枠:At delivery
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Spontaneous delivery, operative vaginal delivery, cesarean delivery
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At delivery
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Indication for delivery
時間枠:At delivery
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At delivery
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Total gestational weight gain
時間枠:From immediately preconception until delivery
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From immediately preconception until delivery
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Postpartum weight retention
時間枠:Within 1 year of delivery
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Within 1 year of delivery
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Diagnosis of Preeclampsia
時間枠:From 20 weeks gestation until 6 weeks postpartum
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From 20 weeks gestation until 6 weeks postpartum
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協力者と研究者
捜査官
- 主任研究者:Hilary A Roeder, MD、UC San Diego Health System
- 主任研究者:Gladys A Ramos, MD、UC San Diego Health System
- 主任研究者:Thomas R Moore, MD、UC San Diego Health System
出版物と役立つリンク
一般刊行物
- 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.
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研究の完了 (実際)
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最終確認日
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本研究に関する用語
キーワード
その他の研究ID番号
- UCSD-GDM-RCT
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