MGA031, Sirolimus and Tacrolimus in Islet Transplantation
Type 1 Diabetes MellitusHypoglycemiaThis clinical trial is designed to extend the observations made in our pilot clinical trial (IND 8971, Study #1) on the safety and efficacy of immunotherapy with the anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala), (currently called MGA031) combined with sirolimus and tacrolimus in preventing rejection and autoimmune destruction of deceased donor pancreatic islet transplants in type 1 diabetic recipients.
The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric...
HypoglycemiaObesity1 moreThis is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.
The Impact of a Predictive Hypoglycaemia Alert Function in Physical Activity for People With T1DM...
Type1diabetesObservational, within-subject, crossover study To assess the impact of Dexcom G6 RT-CGM with a predictive hypoglycaemia alert function on the frequency, duration and severity of hypoglycaemia occurring before, during and after regular physical activity in people with type 1 diabetes At Imperial College Healthcare NHS Trust have established the multi-disciplinary Imperial Physical Activity and Diabetes (IPAD) clinic to empower, educate and enable people with diabetes to manage their blood glucose when they undertake physical activity. The investigator utilise the skills and expertise of a consultant diabetologist, a diabetes dietitian, a consultant in sports & exercise medicine, and a diabetes specialist nurse with expertise in diabetes technology. The investigator have access to diagnostic & therapeutic radiology, physiotherapy and psychology services.
Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous...
HypoglycemiaThe purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4 mg/mL following IV administration at increasing doses in healthy volunteers. One cohort of subjects will receive a SC dose of dasiglucagon to characterize the bioavailability of dasiglucagon following SC administration compared to IV administration. Furthermore, the trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc) prolongation via a concentrationresponse analysis.
Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults
Diabetes MellitusType 1The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally compared with commercially available glucagon given by intramuscular injection.
Randomized Crossover Study to Test the Impact of Using a Software for Smartphones and Tablets in...
Type 1 DiabetesQuality of Life1 moreThe purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life
The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY)...
HypoglycemiaOne of the emerging complications of RNY gastric bypass surgery is mild to severe refractory/ recurrent postprandial hypoglycemia. This complication can lead to a significant reduction in quality of life to severe disability. Unfortunately at this time there are no treatment guidelines or proven therapeutic options for the treatment of this complication. One of the proposed treatment options is the use of fiber supplements to help modify the absorption of glucose, slow the food bolus transit time more toward normal and restore the postprandial (after meal) glucose homeostasis. The investigators are proposing a pilot project for the use of Glucomannan soluble fiber as a treatment option for postprandial hypoglycemia in this cohort. This project will help the investigators to identify if Glucomannan soluble fiber can be used as an effective dietary supplement to eliminate or reduce this condition
Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons
HypoglycemiaBIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
Pharmacological ActionSitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of hypoglycemic episodes in the case that they should occur. The endpoints have defined such that consequences of this hypothesis can be measured.
Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp....
HypoglycemiaThe trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as compared to marketed glucagon.