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UPDATE:2009 DONALD R. COUSTAN, MD NOVEMBER 11, 2009 DIAGNOSTICRECOMMENDATIONS DIAGNOSTIC RECOMMENDATIONS Carbohydrate intolerance, of “EXCEPT FOR RESEARCH PURPOSES, ALL FORMS OF OXFORD: 1989, P 409 SERVICES TASK FORCE SCREENING FOR GESTATIONAL 101:393, 2003 NY:Springer-Verlag, 1978, 425 116:901, Perinatal Mortality vs 2 hr Glucose 100 120 140 Deathsper 40 60 80 100100- 119 120- 159 160- 199 200 per 1000 Live Plasma Glucose (mg/dl) 161:638, 1989 itltlit PERINATALMORBIDITY SHOULDERDYSTOCIA CHILDHOODANDADULT EFFECT ON OFFSPRING 25/40 (63%) 6/24 (25%) 12/51 (24%) 15/82 (18%) 101-119 Pettitt et al: TEST CRITERIA FASTING90 mg/dl 16/ 2 HOURS143 mg/dl 3 HOURS127 mg/dl VENOUS WHOLE BLOOD, SOMOGYI-NELSON FASTING90 mg/dl 16/ 2 HOURS145 mg/dl 3 HOURS125 mg/dl VENOUS WHOLE BLOOD, SOMOGYI-NELSON FASTING105 mg/dl 1HOUR 190mg/dl 2 HOURS165 mg/dl 3 HOURS145 mg/dl VENOUS PLASMA OR SERUM FASTING95 mg/dl 10/ mg 2 HOURS155 mg/dl 3 HOURS140 mg/dl VENOUS PLASMA, GLUCOSE OXIDASE “HEAD-TO-HEAD” TEST NDDGC&C 105*95* 190180* 165155* 145140* VALUE WITHIN 95% CONFIDENCE LIMITS OF SACKS’ CONVERSIONS THE HAPO STUDY HAPO STUDY ~23,000 NON-DIABETIC GRAVIDAS 13 CENTERS 10DIFFERENTCOUNTRIES DIFFERENT COUNTRIES BLINDED 75 GM OGTT 24-28 WEEKS EXCLUDED IF FBS 105 MG/DL, OR 2-HR 200 MG/DL HAPO STUDY CORD BLOOD C-PEPTIDE RELATIONSHIP HOLDS EVEN DOWN TO LOWER LEVELS OF GLUCOSE Fasting Glucose Categories mg/dlmmol/LN% 75 4.2 75-794.2 –4.4 6191 266 85-894.8 –4.9 11.8 90-945.0 –5.2 95-995.3 –5.5 100 219 0.9 23,316 100.0 mg/dlmmol/LN% 110 6.2 110 –1296.2 –7.2 130 -1497.3 5,380 23.1 150 -1698.4 –9.4 170 -1899.5 –10.5 190 -20910.6 – 11.6 210 11.7 Glucose & 1 Birth Weight 90th Percentile Frequency (%) Fasting One Hour Two Hour Primary C-Section Frequency (%) Fasting One Hour Two Hour 1234567 Glucose Categories 1234567 Glucose Categories Clinical Hypoglycemia 1234567 Glucose Categories Frequency (%) Fasting One Hour Two Hour Cord C-Peptide 90th Percentile 1234567 Glucose Categories Frequency (%) Fasting One Hour Two Hour HAPO STUDY STRONG AND SIGNIFICANT PEPTIDEAND NEONATAL SKIN FOLDS 90 PERCENT NEONATAL BODY FAT 90 HAPO STUDY THUS MATERNAL GLUCOSE IS LINKED TO NEONATAL ADIPOSITY,PRESUMABLY ADIPOSITY, PRESUMABLY Adjusted Odds Ratios: Maternal Glycemia as Continuous Variable & OutcomeFasting1-Hour2-Hour Birthweight 90% 1.38 (1.32- 1.46 (1.39-1.53)1.38 (1.32-1.44) 90% Primary C- section 1.11 (1.06-1.15)1.10 (1.06-1.15)1.08 (1.03-1.12) Clinical Neo Hypo 1.08 (0.98-1.19 1.13 (1.03-1.26) 1.10 (1.00-1.12) Cord serum C- Peptide 90% 1.55 (1.47-1.64)1.46 (1.38-1.54)1.37 (1.30-1.44) *Odds ratios for glucose level 1 SD (F=6.9; 1-hr=30.9; 2-hr=23.5 mg/dl) Adjusted Odds Ratios: Maternal Glycemia as Continuous Variable & Secondary Outcomes OutcomeFasting1-Hour2-Hour Premature Delivery (37 wks) 1.05 (0.99-1.11) 1.18 (1.12-1.25)1.16 (1.10-1.23) Shoulder Dystocia/Birth Injury 1.18 (1.04-1.33)1.23 ( 1.09-1.38)1.22 (1.09-1.37) care 0.99 (0.94-1.05 1.07 (1.02-1.13)1.09 (1.03-1.14) Hyperbilirubinemia 1.00 (0.95-1.05) 1.11 (1.05-1.17)1.08 (1.02-1.13) Preeclampsia1.21 (1.13-1.29) 1.28 (1.20-1.37)1.28 (1.20-1.37) *Odds ratios for glucose level 1 SD (F=6.9; 1-hr=30.9; 2-hr=23.5 mg/dl) HAPO STUDY NEED FOR INTERNATIONAL AGREEMENT ON GTT CRITERIA CONSENSUSCONFERENCEHELD CONSENSUS CONFERENCE HELD IN PASADENA, JUNE 2008 SPONSORED BY IADPSG HAPO STUDY QUESTIONS ADDRESSED INCLUDED: WHAT ADVERSE OUTCOMES SHOULD WE USE TO BASE THRESHOLDS? WHAT DEGREE OF RISK FOR ADVERSE OUTCOMES SHOULD TRIGGER SHOULD WE USE FASTING GLUCOSE, POST- LOAD GLUCOSE, OR A COMBINATION FOR HAPO STUDY IADPSG WORK GROUP DEVELOPING CONSENSUS RECOMENDATONS RECOMENDATONS PROJECTED PUBLICATION DATE: SPRING 2010 DO WE NEED TO TREAT F.R.A.C.P.,WilliamS.Jeffries,F.R.A.C.P.,JeffreyS. F.R.A.C.P., William F.R.A.C.P., Robinson, F.R.A.N.Z.C.O.G. and the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group N Engl J Med Volume 352;24:2477-2486 June 16, 2005 Effect of Treatment of FPG 140 MG/DL 2 HOUR PG 140-200 MG/DL INTERVENTION GROUP (N=490) ROUTINE CARE GROUP (N=510) Effect of Treatment of INTENDED TO PRACTICED GIVEN THE DX OF GDM Effect of Treatment of INTENDED TO TOLD THAT THEY DID NOT HAVE GDM CAREGIVER COULD TEST FOR GDM IF JUDGED CLINICALLY INDICATED AT LEAST 20% OF POPULATION WITH NORMAL GTT WERE ADDED TO THIS GROUP TO HELP MAINTAIN BLINDING Effect of Treatment of DEATH SHOULDER DYSTOCIA BONE FRACTURE NERVE PALSY ADMISSION TO NICU INDUCTION OF LABOR CESAREAN SECTION Effect of Treatment of DEATH 05(1%)0.07 SH DYSTOCIA 7(1%)16(3%)0.46 01(1%)0.038 NERVE PALSY 03(1%)0.11 Effect of Treatment of ROUTINE SECONDARY OUTCOMES LGA 90 %ILE 68 (13%)115 (22%)0.001 49(10%)110(21%)0.001 33 (7%)38 (7%)0.59 IV FOR HYPOGLY 35 (7%)27 (5%)0.16 •This large randomized trial of the commonamongtheoffspringofwomen offspring women USUAL PRENATAL CARE (n=473) COHORT OF NL OGTTs ADDED TO ALLOW MASKING OF UNTREATED GROUP TREATED GDM (n=485) BIRTH TRAUMA CORD C-PEPTIDE 90%ILE 3408gVS3302g(p0001) BIRTH WEIGHT 4000 g REDUCED WITH 14% VS 6% (p0.001) 145%VS7%(p0001 NEONATAL FAT MASS REDUCED WITH 464 g VS 427 g (p=0.003) SHOULDERDYSTOCIA(4%vs15% p=0.02), PREECLAMPSIA AND GESTATIONAL HYPERTENSION (14% VS 9%, p=0.01) NO DIFFERENCE IN SGA SHOLD WE TREAT GDM? TREATMENT APPEARS TO BE ONLY 8% IN TREATMENT GROUP REQUIRED INSULIN Management of Gestational If they cross the placenta, and stimulate dibtiftth Mainly case series’ and anecdotes with first generation agents Glyburide initially shown to cross placenta Randomized trial glyburide vs insulin 404 GDMs FPG 95 but 140 m /dl or 2- 4% of glyburide group had to go on insulin Rates of C/S, macrosomia, neonatal hypoglycemia all similar THE PROBLEM: Ratio of umbilical cord to plasma glyburide concentration averaged 0.7 THE PROBLEM: 70%OFMATERNALCONCENTRATIONS INSULIN SENSITIZERS Enhance insulin action, stimulating glucose uptake in liver and periphery, and suppressinghepaticglucoseoutput Only work when in Could this cause macrosomia and other Rowan JA, Hague WM, Gao WH insulin for the treatment of Randomized prospective trial Open label 10 hospitals in Australia, New Zealand DIAGNOSIS OF GDM 75 GM, 2-HR OGTT 99 MG/DL, AND/O ELIGIBLE FOR TRIAL IF, AFTER OR MORE CAPILLARY BLOOD GLUCOSE VALUES 97 MG/DL FASTING OR POSTPRANDIAL 20-33 WEEKS AT ENTRY RANDOMIZED TO ORTWICEDAILYWITH MEALS, INCREASED AS NEEDED TO A MAXIMUM OF 2500 MG/D, (N=363) OR INSULIN PER USUAL OUTCOMES COMPOSITE OUTCOME INCLUDED NEONATAL HYPOGLYCEMIA NEED FOR PHOTOTHERAPY BIRTH TRAUMA 5 MIN APGAR 7 PREMATURE BIRTH (37 WKS) INFANT OUTCOMES SAME IN BOTH GROUPS (32%) SKINFOLD THICKNESS THE CORD INSULIN THE SAME MATERNAL OUTCOMES GLUCOSE CONTROL SIMILAR LOWER2 HRAVERAGE GLUCOSE (112 MG/DL VS 115 MG/DL, P=0.003) WOULDCHOOSETHEIR ASSIGNED TREATMENT ALLMOTHERSTOOKMETFORMIN MOTHERS TOOK THROUGHOUT PREGNANCY MATERNAL SERUM, CORD ARTERY MEDIAN CONCENTRATIONS ( MATERNALCORD VEINCORD ARTERY 1.502.813.16 DO WE NEED TO CONTINUE METFORMIN THROUGHOUT PREGNANCY IN WOMEN WHO CONCEIVE ON THIS MEDICATION? 90:4068, 2005 38%), p=0.045 90:4068, 2005 ovariandiathermy(N 60)totreat (N60) obese anovlulatory PCO patients 89:4801, 2004 Spontaneousabortionratelower(4/43,9%) lower 9%) 89:4801, 2004 iii onal d New Engl J Med HAPO Study Cooperative Research Group: Hyperglycemia and Adverse O(AO) J fiii HAPO Study Cooperative Research Group: Hyperglycemia and Adverse O(AO)S Associations with neonatal and recommendations of ndrome. pyyyy Fertility Sterility 2008;358:2003-2015.