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Lee P.A.,Penn State College of Medicine | Lee P.A.,Indiana University | Klein K.,University of California at San Diego | Mauras N.,Nemours Childrens Clinic | And 6 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: GnRH agonist (GnRHa) monthly injections are frequently used in the treatment of central precocious puberty (CPP). The 3-month leuprolide depot 11.25- and 30-mg formulations are newly approved treatment options. Objective: The aim of the study was to investigate the safety and efficacy of leuprolide acetate 3-month depot formulations for the treatment of CPP in children. Design: This was a phase III, randomized, open-label, dose-ranging 6-month study. Setting: Twenty-two U.S. medical centers (including Puerto Rico) participated. Patients: Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited. Chronological age at onset of pubertal signs was less than 8 yr in girls and less than 9 yr in boys, and bone age was advanced over chronological age at least 1 yr. Intervention: Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months. Main Outcome Measures: Biochemical [peak-stimulated LH, estradiol (girls), and testosterone (boys)] and anthropometric (growth rate, bone age acceleration, pubertal progression) parameters and safety were assessed. Results: Peak-stimulated LH was suppressed in the 11.25-and 30-mg dose groups in 78.4 and 95.2%, respectively, of children from months 2 through 6. There were nine treatment failures (peakstimulated LH >4 IU/liter) in the 11.25-mg group and two in the 30-mg group. Basal sex steroid suppression, growth rates, pubertal progression, bone age advancement, and adverse events were similar with either dose. Conclusions: Treatment with leuprolide acetate 3-month depot formulations (11.25 and 30 mg) effectively suppressed the GnRH axis, was well tolerated, and may positively impact patient convenience and compliance. Copyright © 2012 by The Endocrine Society. Source


Lenz A.M.,Pediatric Endocrine Associates | Root A.W.,University of South Florida
Pediatric Endocrinology Reviews | Year: 2012

An empty sella (ES) develops when cerebrospinal fluid (CSF) fills the sella turcica and compresses pituitary tissue until it lines the sellar floor and walls. Primary ES occurs when CSF enters the sella through a rent in the sellar diaphragm that may or may not be associated with increased intracranial pressure. Secondary ES is a result of an injury to the pituitary itself (e.g., pituitary apoplexy) or the consequence of surgical or radiation treatment. In adults, ES is most commonly found in older, obese, hypertensive, multiparous women and may be asymptomatic. In children, however, ES is more likely to be associated with clinical symptoms and endocrinopathies, particularly growth hormone deficiency, hypogonadotropism, or multiple pituitary hormone deficiencies. The incidence of ES in children varies greatly depending on the population surveyed, ranging from 1.2% (children without endocrine symptoms) to 68% (children with known endocrinopathy). Children with a finding of ES require endocrinologic and ophthalmologic evaluation. Treatment of ES includes replacement of hormone deficiencies and occasionally surgical measures to relieve obstructive intracranial lesions. Source


Yi-Frazier J.P.,University of Washington | Yi-Frazier J.P.,Seattle Childrens Research Institute | Hood K.,Cincinnati Childrens Hospital Medical Center | Case D.,Wake forest University | And 9 more authors.
Diabetes Research and Clinical Practice | Year: 2012

Aims: To identify demographic, family and clinical characteristics associated with provider recommended frequency of blood glucose monitoring (BGM), actual frequency of BGM, and concordance between these categories in youth with type 1 diabetes (T1D) as reported by child's caregiver. Methods: Caregivers of 390 children 10-17 years were interviewed about their children's providers' recommendations for frequency of BGM and their child's frequency of performance of BGM. Results: The majority (92%) of caregivers reported being told that their child should BGM ≥4 times per day and 78% reported their child checked that frequently. Caregivers of children who were younger, non-Hispanic White, from two-parent households, higher income households, and on insulin pumps were more likely to report being told by their provider to perform BGM ≥6 times per day and more likely to report that their child performed BGM ≥6 times per day. Younger children and those with private health insurance were more likely to adhere to reported recommendations. Children whose caregivers reported that their child met/exceeded their provider recommendations had lower A1c values than those who did not. Conclusions: These findings may help clinicians identify subgroups of youth at-risk for poor diabetes management and provide further education in order to improve outcomes. © 2011 Elsevier Ireland Ltd. Source


Sharma A.,Augusta University | Purohit S.,Augusta University | Sharma S.,Augusta University | Bai S.,Augusta University | And 7 more authors.
Frontiers in Endocrinology | Year: 2016

Aims: Reduced levels of free and total insulin-like growth factor 1 (IGF-I) have been observed in type-1 diabetes (T1D) patients. The bioavailability of IGF-I from the circulation to the target cells is controlled by multifunctional IGF-binding proteins (IGFBPs). The aim of this study was to profile serum IGFBPs in T1D and its complications. Design: We measured the IGFBP levels in 3662 patient serum samples from our ongoing Phenome and Genome of Diabetes Autoimmunity (PAGODA) study. IGFBP levels of four different groups of T1D patients (with 0, 1, 2, and ≥3 complications) were compared with healthy controls. Results: Three serum IGFBPs (IGFBP-1, -2, and -6) are significantly higher in T1D patients, and these alterations are greater in the presence of diabetic complications. IGFBP-3 is lower in patients with diabetic complications. Analyses using quintiles revealed that risk of T1D complications increases with increasing concentrations of IGFBP-2 (fifth quintile ORs: 18-60, p < 10-26), IGFBP-1 (fifth quintile ORs: 8-20, p < 10-15), and IGFBP-6 (fifth quintile ORs: 3-148, p < 10-3). IGFBP-3 has a negative association with T1D complications (fifth quintile ORs: 0.12-0.25, p < 10-5). Conclusion: We found that elevated serum levels of IGFBP-1, -2, and -6 were associated with T1D, and its complications and IGFBP-3 level was found to be decreased in T1D with complications. Given the known role of these IGFBPs, the overall impact of these alterations suggests a negative effect on IGF signaling. © 2016 Sharma, Purohit, Sharma, Bai, Zhi, Ponny, Hopkins, Steed, Bode, Anderson and She. Source


Sharma S.,Georgia Regents University | Purohit S.,Georgia Regents University | Sharma A.,Georgia Regents University | Hopkins D.,Georgia Regents University | And 5 more authors.
Mediators of Inflammation | Year: 2015

Aims. To examine the association of the serum levels of TNF receptors, adhesion molecules, and inflammatory mediators with diabetic retinopathy (DR) in T1D patients. Methods. Using the multiplex immunoassay, we measured serum levels of eight proteins in 678 T1D subjects aged 20-75 years. Comparisons were made between 482 T1D patients with no complications and 196 T1D patients with DR. Results. The levels of sTNFR-I, sTNFR-II, CRP, SAA, sgp130, sIL6R, sVCAM1, and sICAM1 were significantly higher in the T1D patients with DR as compared to T1D patients with no complications. Multivariate logistic regression analysis revealed significant association for five proteins after adjustment for age, sex, and disease duration (sTNFR-I: OR=1.57, sgp130: OR=1.43, sVCAM1: OR=1.27, sICAM1: OR=1.42, and CRP: OR=1.15). Conditional logistic regression on matched paired data revealed that subjects in the top quartile for sTNFR-I (OR=2.13), sTNFR-II (OR=1.66), sgp130 (OR=1.82), sIL6R (OR=1.75), sVCAM1 (OR=1.98), sICAM1 (OR=2.23), CRP (OR=2.40) and SAA (OR=2.03), had the highest odds of having DR. Conclusions. The circulating markers of inflammation, endothelial injury, and TNF signaling are significantly associated with DR in patients with T1D. TNFR-I and TNFR-II receptors are highly correlated, but DR associated more strongly with TNFR-I in these patients. © 2015 Shruti Sharma et al. Source

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