2,16-Kauranediol

The representativeness of eligible patients in type 2 diabetes trials: a case study using GIST 2.0.[Pubmed:29025047]

J Am Med Inform Assoc. 2017 Sep 13. pii: 4157244.

Objective: The population representativeness of a clinical study is influenced by how real-world patients qualify for the study. We analyze the representativeness of eligible patients for multiple type 2 diabetes trials and the relationship between representativeness and other trial characteristics. Methods: Sixty-nine study traits available in the electronic health record data for 2034 patients with type 2 diabetes were used to profile the target patients for type 2 diabetes trials. A set of 1691 type 2 diabetes trials was identified from ClinicalTrials.gov, and their population representativeness was calculated using the published Generalizability Index of Study Traits 2.0 metric. The relationships between population representativeness and number of traits and between trial duration and trial metadata were statistically analyzed. A focused analysis with only phase 2 and 3 interventional trials was also conducted. Results: A total of 869 of 1691 trials (51.4%) and 412 of 776 phase 2 and 3 interventional trials (53.1%) had a population representativeness of <5%. The overall representativeness was significantly correlated with the representativeness of the Hba1c criterion. The greater the number of criteria or the shorter the trial, the less the representativeness. Among the trial metadata, phase, recruitment status, and start year were found to have a statistically significant effect on population representativeness. For phase 2 and 3 interventional trials, only start year was significantly associated with representativeness. Conclusions: Our study quantified the representativeness of multiple type 2 diabetes trials. The common low representativeness of type 2 diabetes trials could be attributed to specific study design requirements of trials or safety concerns. Rather than criticizing the low representativeness, we contribute a method for increasing the transparency of the representativeness of clinical trials.

Clinical manifestations of Rathke's cleft cysts and their natural progression during 2 years in children and adolescents.[Pubmed:29025202]

Ann Pediatr Endocrinol Metab. 2017 Sep;22(3):164-169.

PURPOSE: Rathke's cleft cyst (RCC) is an asymptomatic benign lesion. With increased interest in pediatric endocrinology, the prevalence of RCCs in children is also increasing. However, the clinical relevance and proper management of RCC is not well defined in children. Therefore, we investigated the clinical manifestations and radiologic features of RCC in children and adolescents, as well as the natural progression of RCC. METHODS: We retrospectively reviewed the medical records of 91 children and adolescents with RCC diagnosed with magnetic resonance imaging (MRI) in Severance Children's Hospital from January 2006 to December 2015. The clinical, hormonal, and imaging findings were analyzed in patient groups classified according to age. The size of each cyst was assessed in sixty patients who underwent follow-up MRI during the 2 years. RESULTS: Female patients were predominant (64 vs. 27). The common clinical features at presentation were endocrine dysfunction (59.3%), headache (23.0%), and dizziness (4.4%). Symptoms related to endocrine disorders were more frequent in younger patients. In 7 patients managed surgically, the cysts were significantly larger and more frequently located in the suprasellar region. Of 60 nonsurgical patients with a follow-up MRI performed within 2 years after the diagnosis, the RCC size increased in about 26.7% (n=16). CONCLUSIONS: Although 94.4% of the patients with RCC had clinical symptoms, surgery was performed in only about 7.5% of patients. RCC is associated with pituitary insufficiency, thus, baseline and follow-up endocrine function tests are required. Additionally, regular MRI follow-up is required in long-term period to monitor change in size.

The Relationship between Vitamin D and Type 2 Diabetes Is Intriguing: Glimpses from the Spect-China Study.[Pubmed:29024934]

Ann Nutr Metab. 2017;71(3-4):195-202.

OBJECTIVE: Vitamin D is a multifunctional vitamin for our body. Type 2 diabetes mellitus (T2DM) is a common metabolic disease. Whether T2DM affects the serum 25(OH)D level has not been reported. The objective of this study was to reveal the extent to which vitamin D is present in the population in East China and to explore the relationship between serum 25(OH)D and T2DM. METHODS: The cohort was selected based on a large investigation named Survey on Prevalence in East China including 12,702 participants aged 21-92 years old. All the participants completed the questionnaire and went through a physical examination. Fasting blood samples were collected to test serum 25(OH)D and other metabolism-related indicators. AVONA was used to test the significance of differences among groups. Multinomial logistic regression was used to assess the association of T2DM with serum 25(OH)D level. RESULTS: The overall percentage of vitamin D deficiency was 80.55% (male 74.1%, female 85.0%). Men with lower serum 25(OH)D level had high value in homeostasis model assessment of insulin resistance and HbA1c. The serum 25(OH)D level of those who were diagnosed with T2DM was higher than that in non-diabetics. The serum 25(OH)D level of pre-diabetes was the highest. T2DM patients trended to have higher serum 25(OH)D levels. CONCLUSION: Vitamin D deficiency is common among the people in East-China. T2DM patients had higher levels of serum 25(OH)D. The relationship between vitamin D and T2DM is intriguing. It seemed that vitamin D was either irrelevant directly to T2DM or resisted in T2DM patients.