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A Randomized, Double-Blind, Placebo-Controlled Trial Of Adjunctive Metformin Therapy In Overweight/Obese Youth With Type 1 Diabetes, Benjamin U. Nwosu, Louise Maranda, Karen Cullen, Lisa Greenman, Jody Fleshman, Nancy Mcshea, Bruce A. Barton, Mary M. Lee

Mary M. Lee

CONTEXT: Insulin resistance has been proposed as one of the causes of poor glycemic control in overweight/obese youth with type 1 diabetes (T1D). However, the role of adjunctive metformin, an insulin sensitizer, on glycemic control in these patients is unclear.

OBJECTIVE: To compare the effect of metformin vs. placebo on hemoglobin A1c (HbA1c), total daily dose (TDD) of insulin, and other parameters in overweight/obese youth with T1D.

HYPOTHESIS: Adjunctive metformin therapy will improve glycemic control in overweight/obese youth with T1D.

DESIGN, SETTING, AND PARTICIPANTS: A 9-mo randomized, double-blind, placebo controlled trial of metformin and placebo in 28 subjects (13m/15f) of …

Understanding Multifactorial Influences On The Continuum Of Maternal Weight Trajectories In Pregnancy And Early Postpartum: Study Protocol, And Participant Baseline Characteristics, Tiffany A. Moore Simas, Silvia Corvera, Mary M. Lee, Ningning Zhang, Katherine Leung, Barbara C. Olendzki, Bruce A. Barton, Milagros C. Rosal

Mary M. Lee

BACKGROUND: Maternal and offspring immediate and long-term health are affected by pregnancy weight gain and maternal weight. This study was designed to determine feasibility of: 1) recruiting a socio-economically and racially/ethnically diverse sample of pregnant women into a longitudinal observational study, including consenting the women for serial biologic specimen evaluations; 2) implementing comprehensive assessments (including biologic, anthropometric, behavioral, cognitive/psychosocial and socio-demographic, and cultural measures) at multiple time points over the study period, including collecting biologic specimens at planned and unplanned pregnancy delivery times; and 3) retaining the sample for one year into the postpartum period. Additionally, the study will provide …

Vitamin D Status Is Associated With Early Markers Of Cardiovascular Disease In Prepubertal Children, Benjamin U. Nwosu, Louise Maranda, Karen Cullen, Carol A. Ciccarelli, Mary M. Lee

Mary M. Lee

Background: The associations of 25-hydroxyvitamin D [25(OH)D], non-high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL), and related markers of early cardiovascular disease (CVD) are unclear in prepubertal children. Objective: To investigate the association of 25(OH)D with markers of CVD. The hypothesis was that 25(OH)D would vary inversely with non-HDL-C. Subjects and methods: A prospective cross-sectional study of children (n=45; 26 males, 19 females) of mean age 8.3 ± 2.5 years to investigate the relationships between 25(OH)D and glucose, insulin, high-sensitivity C-reactive protein, and lipids. Vitamin D deficiency was defined as 25(OH)D/mL; overweight as body mass index (BMI) ≥ 85 th but …

Parental Mastery Of Continuous Subcutaneous Insulin Infusion Skills And Glycemic Control In Youth With Type 1 Diabetes, Kathleen Mitchell, Kimberley Johnson, Karen Cullen, Mary M. Lee, Olga T. Hardy

Mary M. Lee

OBJECTIVE: The purpose of this study is to determine whether parental knowledge of the continuous subcutaneous insulin infusion (CSII) device affects glycemic control as measured by hemoglobin A1c (A1C) level. SUBJECTS AND METHODS: Parents of children with type 1 diabetes mellitus (T1DM) using CSII completed a 14-item questionnaire. Questions 1-10 were knowledge-based questions that required the parent to extract specific information from their child's CSII device. Questions 11-14 asked parents to provide a self-assessment of their CSII knowledge. RESULTS: Twenty-two parents of youth with T1DM participated in the study. Ten of the youth were in the Low-A1C group (A1C/=8%). Parents …