Mean HPO Fasting Plasma Glucose

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Presentation transcript:

Mean HPO Fasting Plasma Glucose Myo-inositol supplementation: an alternative to insulin therapy for gestational diabetes mellitus (GDM) Vanessa Lubin1, B. Pfister1, JP. Chalabreysse1, F. Audibert1, A. Boyer1, C. Cuenin1, M. Inguimbert1, M. Lecat1, O. Marpeau1, R. Shojai1, P. Darmon 2 1 Maternité, Clinique de l’Etoile, Aix en Provence, France 2 Endocrinologie et Maladies Métaboliques, Hôpital Sainte Marguerite, Marseille, France Background: Since we apply IADPSG diagnostic criteria for gestational diabetes mellitus (GDM), we observed a rise in GDM diagnosed on elevated fasting plasma glucose (FPG > 92 mg/dl) In this group of patients, obesity is frequent, achieving glycemic goals is challenging and often requires insulin. Myo-inositol (MI) is an isomer of the alcohol sugar C6 and a member of the B-vitamin family. It belongs to the phosphatidylinositol system of signal transduction, known to be involved in insulin signaling. MI increases insulin sensitivity, enhancing glucose uptake and cellular metabolism. Available data suggest that MI could be useful to achieve glycemic control in GDM patients having high FPG despite good diet observance. Design: Population: Patients are followed up during their pregnancy in « Maternité Catholique de l’Etoile », Puyricard, Aix en Provence, France. Patients are citizens from Aix en Provence and its surrounding, or come from rural zone of « hautes Alpes » and « Alpes de haute Provence » Clinic: 7 obstetricians, 6 medical gynecologists, 2 endocrinologists, one dietician, 3 pediatricians. Protocol: We report a prospective case-control study, including 61 patients, of oral MI supplementation, available in France as Inofolic® (MI 600 mg and Folic Acid 100ug) as an alternative to insulin treatment in this group of GDM patients. The insulin treated control group (group A) was constituted in 2013 among 119 GDM patients: after 2 weeks of controlled diet, 28 still had high fasting glycemia > 0,95 mg/dl on self-monitoring glucose control, and required insulin therapy. The treatment group (group B) included the 33 patients who did not reach fasting glycemia goals on self-monitoring among the 120 GDM diagnosed in 2014, and were therefore eligible to insulin therapy. Group B patients underwent self-monitoring glucose control, with MI treatment, and were reevaluated 2 weeks after. Insulin treatment was then started if glycemic goals weren’t achieved (more than 4/42 glycemias per week over the objectives). In group B, patients were more frequently obese as expected in GBD patients with high fasting plasma glucose. Table 1: Patients Characteristic Results: In group B patients had 16/42 (+/- 6) glycemias/week above objectives. Inofolic® was administered as 2 tab/day, patients were reevaluated 2 weeks later. Only 8 patients still had fasting hyperglycemia and required insulin. Otherwise MI was maintained , we observed in theese patients that glycemic control was maintained during all pregnancy with MI. Birth term and birthweight in MI treatment group weren’t different compared to the control group. The rate of cesarean section was higher in the MI Treatment. Among cesarean section, 3/14 = 21% were performed after failed induced labour, 6/14 = 42% were performed in obese patients, and 5/14 = 35.7% in insulin treated patients. So 44.4% of obese patients, and 40% of non obese patients, delivered with a cesarean section (NS). Among insulin treated patients 55.5% delivered with cesarean section. Among the “MI only” treatment group 37.5% did (NS) Table 2 : Pregnancy issues Discussion: This is a pilot ongoing study; results need to be confirmed. Indeed MI seems to be an efficient treatment for controlling FPG in GDM, and a well-tolerated, well-accepted, alternative to insulin. Insulin therapy was avoided in 72.7 % of cases in the MI group. In terms of birth term and birth weight the results seem to be safe. Thus we observed higher cesarean section rate in the MI treatment group, we failed to find a correlation with either obesity, or insulin treatment. We need to enlarge the cohort to collect more data. Number of patients Mean Age    (years  SD) Mean HPO Fasting Plasma Glucose (g/l) Mean HPO 1 H Plasma Glucose 2 H Plasma Glucose Obesity (%) Group B cases 33 33.5  5.7 0.96 1.90 1.62 45.4 Group A controls 28 34.3  4.5 0,95 1.86 1.75 28.5 Number of patients Insulin Treatment (%) Birth Term (SA  SD) Vaginal Cesarean Section Mean Birth weight (g ± SD) Group B Cases 33 27.3 39  1 57.6 42.4 3 555  491 Goup A Controls 28 100 38.8  0,6 75 25 3 400  460 p < 0.01 NS p < 0.05