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Type1diabetes clinical trials

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NCT ID: NCT04219709 Recruiting - Type1diabetes Clinical Trials

Effects of Ketosis on Brain Function in Patients With T1DM

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic [very low carbohydrate] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.

NCT ID: NCT04208282 Completed - Type1diabetes Clinical Trials

Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.

NCT ID: NCT04204733 Completed - Type1diabetes Clinical Trials

Mobile Physical Activity for Type 1 Diabetes

Start date: January 6, 2020
Phase: N/A
Study type: Interventional

The study is the formative observation stage of behavioral intervention development. Sedentary adults with type 1 diabetes will be given access to a mobile application that incorporates biosensor feedback, teleconsultation, and online group exercise classes. The first aim is to quantify the feasibility, acceptability, and preliminary efficacy of the application. The second aim is to evaluate predictors and mechanisms of physical activity behavior change among these adults. The possible predictors the investigators are monitoring include usage of specific application features, momentary internal factors (e.g., pre-activity fear of hypoglycemia), momentary external factors (e.g., location), and latent external factors (e.g., mental health traits). These results will be used to develop a refined mobile application utilizing the most popular application features, as well as an algorithm that uses the identified predictors of physical activity to advise adults with type 1 diabetes when to engage in physical activity (i.e., context-aware physical activity coaching) and when to make related diet and insulin adjustments.

NCT ID: NCT04200391 Recruiting - Type1diabetes Clinical Trials

Very Low Carbohydrate Diets and Glucagon Response in T1DM

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate (VLC) diet. Despite these promising preliminary results, the use of VLC diets for T1D remain controversial, because of their restrictive nature and theoretical concerns regarding growth, ketoacidosis and hypoglycemia risks and efficiency of glucagon treatment for hypoglycemia. Glucagon is used as a rescue medication during severe hypoglycemia and increases blood glucose levels by mobilizing liver glycogen stores. If these stores are depleted during carbohydrate restriction, glucagon response may be inadequate and put individuals at risk for refractory hypoglycemia. A physiologic study has shown a blunted but still adequate response to glucagon in n=10 participants after following a VLCD for 1 week. Longer-term studies have not been done. To test the hypotheses that glucagon response remains adequate while following a VLC diet in the longer term, the investigators will conduct a glucagon challenge in participants who are assigned to the VLC arm of a randomized-controlled feeding study in 32 young adults with T1D who will receive a VLC vs a standard diet for 12 weeks. After an overnight fast, twelve participants in the VLC arm will receive IV insulin to lower blood glucose levels to 60 mg/dL, followed by a glucagon injection and monitoring of blood glucose levels and other metabolic fuels.

NCT ID: NCT04172077 Completed - Type1diabetes Clinical Trials

Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes

Start date: September 18, 2019
Phase:
Study type: Observational

This project will assess self-efficacy levels(SE) ,resiliency and attachment style of adolescent with type 1 diabetes and their caregivers.SE and attachment style of patients and parents will be compared with each other as well as correlated with diabetes management as assessed by A1C and self inventory scale.

NCT ID: NCT04162067 Completed - Type1diabetes Clinical Trials

The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry

Start date: January 6, 2020
Phase:
Study type: Observational

This retrospective study uses the Canadian LMC Diabetes Registry to describe the current health status of Canadians with type 1 diabetes. The study provides a detailed report of the demographic composition, treatment regimens, self-care approaches, health status, metabolic outcomes, and glycemic control of a large Canadian community-based, specialist-led cohort of patients with type 1 diabetes. Specific study outcomes will also be evaluated in a subgroup of patients using continuous subcutaneous insulin infusion (CSII) therapy.

NCT ID: NCT04142944 Completed - Type1diabetes Clinical Trials

The Impact of a Predictive Hypoglycaemia Alert Function in Physical Activity for People With T1DM

PACE
Start date: December 11, 2019
Phase: N/A
Study type: Interventional

Observational, 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.

NCT ID: NCT04141761 Active, not recruiting - Type 1 Diabetes Clinical Trials

Probiotics in Newly Diagnosed T1D

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

NCT ID: NCT04074668 Completed - Diabetes Clinical Trials

Control of Renal Oxygen Consumption, Mitochondrial Dysfunction, and Insulin Resistance

CROCODILE
Start date: January 1, 2020
Phase:
Study type: Observational

Type 1 diabetes (T1D) is a complex metabolic disorder with many pathophysiological disturbances including insulin resistance (IR) and mitochondrial dysfunction which are causally related to the development of diabetic kidney disease (DKD) and which contribute to reduced life expectancy. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. By examining the interplay between factors responsible for increased renal adenosine triphosphate (ATP) consumption and decreased ATP generation in young adults with and without T1D, this study hopes to identify novel therapeutic targets to impede the development of DKD in future trials. The investigators propose to address the specific aims in a cross-sectional study with 30 adults with T1D and 20 controls without a diagnosis of diabetes. For this protocol, participants will complete a one day study visit at Children's Hospital Colorado. Patients will undergo a Dual-energy X-Ray Absorptiometry (DXA) scan to assess body composition, renal Magnetic Resonance Imaging (MRI) to quantify renal oxygenation and perfusion, and a Positron Emission Tomography/Computed Tomography (PET/CT) scan to quantify renal O2 consumption. After the PET and MRI, participants will undergo a hyperinsulinemic-euglycemic clamp to quantify insulin sensitivity. Glomerular Filtration Rate (GFR) and Effective Renal Plasma Flow (ERPF) will be measured by iohexol and PAH clearances during the hyperinsulinemic-euglycemic clamp. To further investigate the mechanisms of renal damage in T1D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.

NCT ID: NCT04073914 Completed - Type1diabetes Clinical Trials

Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes

Type1
Start date: June 29, 2017
Phase: N/A
Study type: Interventional

Type 1 Diabetes (T1DM) is a common chronic illness in children which presents difficult and often stressful management concerns for parents. As children approach adolescence, this burden increases with the desire for independence and self-management. No tool exists that addresses in a user friendly, easy to access and socio-culturally appropriate way, the psychosocial needs of parents as they move through this transition. This program targets the parents to help them at the very point where this transition is occurring.