ABSTRACT
Background: Secondary stroke prevention after a high-risk, non-disabling ischemic cerebrovascular event needs to be enhanced. The study was conducted to investigate whether remote ischemic conditioning (RIC) is effective in preventing recurrent ischemic events within 3 months. Methods: This was a four-center, single-arm, open-label Phase IIa futility trial (PICNIC-One Study). Adult patients (≥18 years of age) who had an acute minor ischemic stroke (AMIS) with a National Institutes of Health Stroke Scale score ≤ 3 or a transient ischemic attack (TIA) with moderate-to-high risk of stroke recurrence (ABCD score ≥ 4) within 14 days of symptom onset were recruited. Patients received RIC as adjunctive therapy to routine secondary stroke prevention regimen. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuffs (45 min) on bilateral upper limbs twice a day for 90 days. Results: A total of 285 patients met the study criteria, of which 167 provided signed informed consent and were enrolled. Data from 162 were analyzed with five subjects excluded. Recurrent AIS/TIA occurred in 6/162 (3.7%) patients within 3 months, with no occurrence of hemorrhagic stroke. The top three adverse events were upper limb pain (44/162, 27.2%), petechia (26/162, 16.0%), and heart palpitation (5/162, 3.1%). About 68 (42.0%) subjects completed ≥ 50% of 45-min RIC sessions. Conclusions: RIC is a safe add-on procedure and it has a potential benefit in reducing recurrent cerebrovascular events in patients with high-risk, non-disabling ischemic cerebrovascular events as the risk of stroke/TIA events is lower than expected; however, its compliance needs to be improved. Our study provides critical preliminary data to plan a large sample size, randomized controlled clinical study to systematically investigate the safety and efficacy of RIC in this population.
ABSTRACT
PURPOSE: Latent autoimmune diabetes in adults (LADA) is a slowly progressing form of immune-mediated diabetes that combines phenotypical features of both type 2 diabetes mellitus (T2DM) and type 1 diabetes mellitus (T1DM), meaning that accurate and early diagnosis of this subtype of diabetes is critical for optimal long-term management. Urinary C-peptide creatinine ratio (UCPCR) represents a non-invasive and practical method for assessing endogenous insulin production to facilitate diabetes classification. However, no study to date has reported the use of UCPCR in identifying LADA. PATIENTS AND METHODS: A total of 574 subjects were included in our study (42 LADA, 61 T1DM, 471 T2DM). All participants were evaluated for UCPCR and underwent clinical and laboratory evaluations. UCPCR was compared among different subtypes of diabetes using multinomial regression analysis, and a receiver operating characteristic (ROC) curve was used to identify its performance in diagnosing LADA. RESULTS: UCPCR was lower in LADA (0.4±0.6 nmol/mmol) compared with T2DM (1.2±0.9 nmol/mmol), but higher than in T1DM (0.2±0.3 nmol/mmol) (p<0.05). The association between UCPCR and LADA remained significant after adjusting for gender, age, age at diagnosis, body mass index, high-density lipoprotein cholesterol, and triglyceride (OR, 95% confidence interval (CI), 0.29 (0.09, 0.95)). The ROC curve revealed an area under the curve of 0.835 (95% CI (0.742-0.928), p<0.001). The cut-off point for UCPCR ≤ 0.46 nmol/mmol was 82.1% for sensitivity and 76.7% for specificity in the diagnosis of LADA. CONCLUSION: UCPCR may represent a non-invasive, simple, and practical measurement of insulin secretion for early discrimination of LADA in routine clinical practice.
