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NCT ID: NCT04268862 Recruiting - Pathophysiology Clinical Trials

Metabolic Defects in Prediabetic Kuwaiti Arabs and Indians

Start date: March 1, 2020
Phase:
Study type: Observational

Insulin resistance and beta cell dysfunction are the major core defects responsible for the development of type 2 diabetes (T2DM). Although insulin resistance is the early metabolic defect detected in subjects destined to develop T2DM, it is the beta cell failure which is responsible for the development of hyperglycemia. Longitudinal and cross-sectional studies have demonstrated that, initially, the compensatory hyperinsulinemia is sufficient to offset the insulin resistance and maintain normal glucose tolerance. However, when the beta cell fails to adequately compensate for the insulin resistance, glucose homeostasis deteriorates. Initially, this is manifest as impaired glucose tolerance (IGT) and later as overt diabetes. It follows that the level of beta cell failure at which hyperglycemia becomes evident depends upon the prevailing level of insulin resistance. A more severe insulin resistance results in development of overt hyperglycemia at lower level of beta cell failure. The investigators previously have shown that the severity of insulin resistance varies amongst different ethnic groups (Arabs versus Indians). Thus, the level of beta cell failure at which overt hyperglycemia becomes evident amongst each ethnic group also varies. Thus, individuals/ethnic groups with more severe insulin resistance, overt hyperglycemia becomes evident at lower level of beta cell dysfunction. Conversely, severe beta cell dysfunction is required for evert hyperglycemia to develop in individuals/ethnicities with less severe insulin resistance. In the present study, the investigators aim to quantitate beta cell function with the gold standard technique (i.e. hyperglycemic clamp) in Arab and Indian non-diabetic individuals and relate the level of beta cell function to the prevailing level of insulin resistance measured as the glucose infusion rate divided by the mean plasma insulin concentration during the clamp.

NCT ID: NCT04153253 Completed - Clinical trials for Diabetic Vitreous Hemorrhage

Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

Start date: March 7, 2018
Phase: Phase 4
Study type: Interventional

Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

NCT ID: NCT04147637 Withdrawn - Clinical trials for Type1 Diabetes Mellitus

FreeStyle Libre Plus Bluetooth Transmitter Adjunct: Can This Improve Glucose Accuracy and Reduce Burden of Hypoglycaemia

FSL-M
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

Advanced glucose monitoring systems have revolutionized diabetes care and enabled people with diabetes to achieve better diabetes control with reduced risk of hypoglycaemia. Continuous glucose monitoring (CGM) systems provide real-time glucose monitoring and alarms when glucose approaches extreme readings (hypoglycaemia and hyperglycaemia) or when the change in glucose is rapid. All available CGM systems, except Dexcom G6, require daily calibrations with capillary glucose readings in order to attain accuracy of glucose readings. Decom G6 system is not widely accessible and only available in certain countries. Flash glucose monitoring systems (Flash) provide glucose readings when users actively scan their sensors. FreeStyle Libre (FSL) is the only Flash glucose monitoring system currently available in market. FSL is factory calibrated and sensors are ready to use after placement and initiation. The two main differences between Flash and CGM are user interaction and the alarm facility. While CGM provide real-time glucose readings, Flash is user-dependent for actively scanning and understanding the readings. Moreover, CGM systems provide alarms for low or high glucose and for rapid glucose changes, while Flash does not routinely provide alarms. This is particularly relevant when patients have impaired or lost hypoglycaemia awareness. CGM systems are costlier compared to Flash, which has contributed to the wider adoption of FSL. Several Bluetooth adjuncts have been introduced to market for FSL. These devices attach to Libre sensor and connect to the user's mobile phone via Bluetooth. This enables continuous and real-time feed of glucose readings from the sensor to patient's mobile phone, which enables a wide range of customizable alarms for high and low glucose levels and for rapid glucose changes. This setup also enables calibration of Libre sensor with capillary glucose which, anecdotally, has been reported to improve sensor accuracy. None of these adjuncts have been validated clinically. FSL with Bluetooth adjunct such as MiaoMiao remain cheaper than current CGM options and could be more accessible in some countries than CGM. However, without robust evidence to support effectiveness and safety of such setup it is not possible to recommend this. The Objective of this study is to determine whether FSL with Bluetooth Adjunct is superior to FSL alone in accuracy and reduction of hypoglycaemia burden.

NCT ID: NCT04146922 Completed - Clinical trials for Escherichia Coli Bacteremia

Switch to Oral Antibiotics in Gram-negative Bacteremia

SOAB
Start date: October 13, 2019
Phase: N/A
Study type: Interventional

Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more and have received microbiologically active intravenous therapy for 3-5 days. The bloodstream isolate must be susceptible to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole and the subject must be able to take oral medication directly or through a feeding tube. Exclusions criteria include allergy to all in-vitro active antimicrobials which are available in oral formulations, pregnancy, infective endocarditis, central nervous system infection, terminal illness with expected survival less than 14 days, absolute neutrophil count less than 1,000/ml and hematopoietic or solid organ transplantation within the preceding 90 days. Randomization will be stratified by urinary versus non-urinary source of bacteremia. The primary outcome is treatment failure at 90-days with 10% margin for non-inferiority in the 95% confidence interval around the difference in outcome between the two study groups.

NCT ID: NCT04136730 Completed - Diabetes Clinical Trials

Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study investigates the effects of home-based resistance exercise training, compared to a control group, on body composition, muscle strength and glycaemic control in people with type 2 diabetes. Half participants will be in the home-based exercise group and half in the control group.

NCT ID: NCT04135287 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Relationship Between Improvement in Insulin Secretion and Decrease in HbA1c in GLP-1 RA Therapy in T2DM Patients

Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

GLP-1 receptor agonists (GLP-1 RA) is group of antidiabetic agents very effective in lowering the plasma glucose concentration in T2DM patients . Currently there are several agents approved for the treatment of T2DM which are classified into two groups: (1) short acting GLP-1 RA and include exenatide BID and lexisenatide, and (2) long acting agents which are given once daily or weekly injection and include liraglutide, semaglutide, dulaglutide and budyreon . Clinical studies have demonstrated that long acting GLP-1 RA (e.g. liraglutide, bydureon and dulaglutide) produce ~1.5% reduction in the HbA1c , which was significantly greater than that caused by other classes of antidiabetic agents (e.g. DPP4 inhibitors, and SGLT2 inhibitors). Members of this class of drugs exert multiple metabolic actions in T2DM. They potentiate insulin-stimulated insulin secretion from the beta cell , inhibit glucagon secretion from the alpha cells and inhibit appetite and promote weight loss. Together, these metabolic actions of GLP-1 RA contribute to the improvement in glucose metabolism and decrease in HbA1c. Although GLP-1 RA produce a robust mean decrease in HbA1c (~1.5%), the magnitude of decrease in HbA1c in the individual patient vary considerably. Clinical studies showed that approximately one third of T2DM patients receiving GLP-1 RA experience very modest to no decrease in the HbA1c while another third of patients experience a robust decrease in the HbA1c. the reason for this large variability in the individual response to GLP-1 RA is unknown. Studies which attempted to identify possible clinical predictors that distinguish between "good responders" and "poor responders" have failed to identify clinical parameter that can predict the magnitude of decrease in HbA1c by GLP-1 RA in T2DM patients. Because of the central role of beta cell function in the regulation of plasma glucose concentration, the study investigators hypothesis that varying degree of beta cell response to GLP-1 RA action is the principal factor responsible for the large variability in the decrease in HbA1c by GLP-1 RA. The aim of the present study is to test this hypothesis.

NCT ID: NCT04135248 Enrolling by invitation - Clinical trials for Type 1 Diabetes Mellitus

A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?

Start date: April 18, 2019
Phase:
Study type: Observational [Patient Registry]

Fasting Ramadan is one of the five pillars of Islam and requested only from healthy adults to abstain from eating and drinking from sunrise to sunset. People with type 1 diabetes mellitus (TIDM) are exempted from fasting, as their chronic condition could be adversely affected by fasting. Nevertheless, many insist on fasting and it has been experienced and advocated that with proper education and follow-up with health care providers, people with uncomplicated T1DM could safely fast Ramadan. Adopted IDF-DAR guidelines for people with diabetes planning to fast Ramadan are available but are based on opinions and largely untested. These current guidelines recommend a significant reduction in insulin doses and a change of the timing of basal insulin and highlight the increased risk of hypoglycemia. Our local DAFNE patient's experience with fasting during the past years points towards no significant changes in insulin timing with minor reductions of insulin without a significant increase in the risk of hypoglycemia. There is no randomized control trial to test the efficacy of the IDF-DAR guidelines specifically looking at changing basal insulin timing This study aims to assess whether insulin doses require reduction and change of timing during Ramadan. We aim to compare the effectiveness and safety of two management strategies. This will help to provide robust guidelines to help both health care professionals and people with type 1 diabetes

NCT ID: NCT04130191 Active, not recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II

ENABLE
Start date: December 11, 2019
Phase:
Study type: Observational

The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started. Data from participants who start the study after 1 March 2021, will be collected for 24 months; data from all other participants (who started the study before 1 March 2021) will be collected for 36 months. Participants will report information in a smartphone application at study start and for the next 3 months and then every 6 months until the study ends; data will also be collected by the study doctor during routine clinic visits

NCT ID: NCT04123002 Completed - Gingivitis Clinical Trials

Effect of Miswak Chewing Sticks on Periodontal Pathogens and Its Impact on the Progression of Gingivitis

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

A cross over randomized clinical trial Group A- Tooth Brush and Paste only Group B- Tooth Brush and Paste and Miswak chewing sticks

NCT ID: NCT04105764 Completed - Muscle Relaxation Clinical Trials

Deep NMB in Ambulatory Gynecological Laparoscopy

Start date: December 1, 2016
Phase: Phase 4
Study type: Interventional

Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR [1,2]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes [3], which could influence the postoperative QOR negatively [4]. Poor postoperative QOR leads to prolonged hospital stay [5].