Abstract
Study Design Single center prospective cross-sectional study Patient Population The AdDIT study is a multi-centre, randomized, double-blind, placebo-controlled, 2x2 factorial design trial of angiotensinconverting enzyme inhibitor and statin therapy vs. placebo in 500 high-risk (>1.2 mg⁄mmol) T1D adolescents, defined on the basis of albumin excretion.1 It also includes a parallel observational study based on longitudinal follow-up of 400 low-risk (<0.8 mg⁄mmol) and medium-risk (0.8-1.2 mg⁄mmol) T1D adolescents who were screened but did not qualify for randomization. Subjects recruited in the current study were lowand mediumrisk from the parallel observational study and high-risk T1D adolescents that declined participation in the randomized controlled trial. All 199 T1D were compared with 178 adolescents recruited as healthy volunteers, who were not on any vasoactive medications, had no previous history of familial hyperlipidemia, diabetes, obesity, hypertension, or any other significant cardiac, renal or systemic disease and normal cardiac anatomy and function by screening echocardiogram. In subgroup analysis, 68 low-, 78 medium-and 53 high-risk were compared with 65 controls that underwent the same baseline clinical assessment. Anthropometric Assessment Height was measured by stadiometer to the nearest 0.1 cm and weight by electronic balance to the nearest 0.1 kg. Resting heart rate and right brachial blood pressure was measured using an age-appropriate cuff and averaging 3 readings with an automated DINAMAP® sphygmomanometer (Critikon, Tampa, Florida, USA). Echocardiographic Assessment Using a Vivid 7 ultrasound system (GE, General Electric Corp., Wisconsin, USA) with appropriate transducers ranging from frequencies 4-12 MHz depending on subject age and size, a standardized functional imaging protocol, including subcostal, parasternal, apical and suprasternal views, was performed according to published guidelines.2 Modalities employed in this study included M-mode, 2D and pulse Doppler blood flow measurements. Laboratory Assessment Glycemic control was measured by fasting blood glucose and haemoglobin A1c. Serum lipids including total, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides were measured. Serum creatinine was used to estimate glomerular filtration rate.3 Statistical Analysis Between groups comparisons were performed using Student’s ttests. Relationships were tested using Pearson’s correlations. Statistical significance was considered at p<0.05.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.