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Type 1 Diabetes clinical trials

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NCT ID: NCT01672255 Recruiting - Type 1 Diabetes Clinical Trials

Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)

Start date: October 2012
Phase: Early Phase 1
Study type: Interventional

Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS responses during exercise.

NCT ID: NCT01580462 Recruiting - Type 1 Diabetes Clinical Trials

The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes

ADHERENCE
Start date: April 2012
Phase: N/A
Study type: Observational

The aim of the research is to develop a mathematical model called ADHERENCE index, and to evaluate its effectiveness.

NCT ID: NCT01559025 Recruiting - Type 1 Diabetes Clinical Trials

Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months). The secondary objectives are: 1. To define the immune and inflammatory profile 2. To define the secretion of glucagon and GLP-1 3. To assess the glycemic variability

NCT ID: NCT01557634 Recruiting - Type 1 Diabetes Clinical Trials

Closing the Loop in Young Children With Type 1 Diabetes

Start date: December 2012
Phase: Phase 2
Study type: Interventional

The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. On both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. The study will take place at the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from paediatric diabetes clinics in England.

NCT ID: NCT01500928 Recruiting - Type 1 Diabetes Clinical Trials

Performance Study of the SOLO 2.0 Insulin Pump

Start date: July 2011
Phase: N/A
Study type: Interventional

The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment.

NCT ID: NCT01402037 Recruiting - Type 1 Diabetes Clinical Trials

Beta Cell Function in (Pre)Type 1 Diabetes

Start date: July 2011
Phase: N/A
Study type: Interventional

Increased glycemic variability has been proposed as an independent predictor of hypoglycemia in diabetic patients. Likewise, episodes of dysglycemia have been found to be predictive of diabetes in antibodypositive nondiabetic individuals. We hypothesise that an in-depth observational study comparing state-of-the-art measures of functional beta cell mass and glycemic variability will specify the relationship between both variables over a broad range of residual function and will identify treatment goals for functional beta cell mass to be reached in future beta cell therapy trials in order to avoid frequent hypoglycemia in patients and dysglycemia in risk groups. The available expertise and infrastructure (see background and (inter)national context) place the promoters of the present project in a unique position to carry out the planned experiments and support their feasibility.

NCT ID: NCT01379729 Recruiting - Type 1 Diabetes Clinical Trials

Bet Cell Therapy in Diabetes Type 1

Start date: May 2011
Phase: Phase 2
Study type: Interventional

Primary outcome measurement is a parameter of functional beta cell mass at 6 months PT. Functional beta-cell mass will be calculated using the AUC/min between 150 and 160 min during hyperglycemic clamp at 180 mg/dl. The investigators hypothesize that functional beta-cell mass will be more than 20% compared to healthy controls. Secondary outcome measurements: Functional beta-cell mass at 2,12,18,24,36,48 and 60 months PT. The investigators will also compare at 2, 6,12, 24,36,48 and 60 months the changes against base-line (base-line = before first intraperitoneal transplantation): - metabolic control - safety parameters - episodes of hypoglycemia - islet cell autoantibodies, lymphocyte subsets, T-cell reactivity against auto- and alloantigens using pre-transplant measurements as base-line The investigators hypothesize that metabolic control and prevalence of hypoglycemia, will be significantly improved till PT month 12. Histopathology of a biopsy specimen of the human intraperitoneal beta cell implant, at time of the second implant. Comparison with composition of graft, identification of microenvironment of host origin and correlation with functional assessment will be performed.

NCT ID: NCT01350219 Recruiting - Type 1 Diabetes Clinical Trials

Stem Cell Educator Therapy in Type 1 Diabetes

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.

NCT ID: NCT01194479 Recruiting - Type 1 Diabetes Clinical Trials

Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.

Start date: August 2010
Phase: N/A
Study type: Interventional

Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

NCT ID: NCT01192711 Recruiting - Type 1 Diabetes Clinical Trials

Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice

DID3
Start date: May 2009
Phase: Phase 3
Study type: Interventional

The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages. Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin glulisine associated with a telemedicine system to teach CHO counting (DID) with the same insulin regimen administered according to usual practice.