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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT03821961 Recruiting - Obesity Clinical Trials

18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery

Start date: September 3, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to compare the endocrine function of pancreas between pre and post metabolic surgery in patients with type 2 diabetes or prediabetes. The study will examine the endocrine function of pancreas using 18F-FDOPA PET/CT imaging and various biochemical laboratory tests

NCT ID: NCT03816280 Recruiting - Diabetes Mellitus Clinical Trials

Cerebrovascular Effects of the Use of Alpha-stat or pH-stat Management of Cardiopulmonary Bypass

Start date: February 1, 2019
Phase:
Study type: Observational

Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate cerebral oxygenation. Furthermore, acid-base balance of patients undergoing CPB can be managed using two main regimes: alpha-stat and pH-stat. The use of pH-stat acid-base management involves maintaining the patient's temperature-corrected pH at a constant level (7.40) and maintaining normocapnia (pCO2 of 40 mmHg). Alpha-stat acid-base management on the other hand is performed by maintaining the ionization state of histidine by keeping the pH stable when a standardized temperature of 37C is used. Therefore, while a constant pH (7.40) and normocapnia (pCO2 of 40 mmHg) are targeted when measured at 37C, the hypothermia applied during CPB will result in a lower pCO2 and in a relative respiratory alkalosis. Previous studies investigating alpha-stat and pH-stat managements demonstrated increased jugular venous oxygen concentrations when pH-stat management was applied. Therefore, our study is aimed at characterizing the effects of an alpha-stat or pH-stat acid-base management regime on the cerebral oxygenation, parameters of regional cerebral oxygen supply and demand during and following CPB in diabetic patients. These parameters include regional cerebral tissue oxygen saturation (rSO2), central venous oxygen saturation ScvO2) and the physiological saturation gap between ScvO2 and rSO2 (gSO2).

NCT ID: NCT03811548 Recruiting - Diabetes Type 2 Clinical Trials

Janagliflozin Treat T2DM Monotherapy

Start date: May 23, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.

NCT ID: NCT03804411 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Prognostic Predictors of Response to Hypoglycemic Therapy

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

This is a randomized controlled trial aimed to determine highly specific personified predictors of response to the therapy by different groups of hypoglycemic drugs (SGLT-2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, sulfonylureas) in patients with type 2 diabetes mellitus, develop an algorithm of personalized therapy based on them, design an organizational and methodological model for prevention of the cardiovascular complications, and create an automated decision-making system for therapy selection to reduce the incidence of cardiovascular events and related adverse outcomes compared to the traditional approach. This is an interventional, randomized controlled trial, open-label study.

NCT ID: NCT03794739 Recruiting - Diabetes Mellitus Clinical Trials

Role of TMEM219 Marker in Type 1 Diabetes

NPOD
Start date: August 8, 2020
Phase:
Study type: Observational

Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. The initial stages of diabetic disease are characterized by the massive and progressive infiltration of T cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. The onset of T1D has been mainly associated to a dysregulation of the immune response. However, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. The investigators have recently shown that the expression of the TMEM219 death factor is an essential factor in controlling the fate of stem cells in diabetes. The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.

NCT ID: NCT03792646 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Protein Supplementation: Body Composition, Muscle Strength and Postural Balance

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Nutritional interventions witch stimulate the rate of muscle protein synthesis are relevant for the development of therapeutic strategies aimed at attenuating the loss of mass and muscle strength related to aging (sarcopenia). To aim of the study is to investigate the effect of protein supplementation on body composition, muscle activity, muscle strength and plasma concentration of inflammatory biomarkers of elderly with type II diabetic, submitted to 12 weeks of resistance training. This is an interventional, controlled, randomized, double-blind study. The population of the present study will be composed of 40 men with type 2 diabetes aged between 70 and 74 years, whose body mass index (BMI) should be between 22 and 32 kg / m2. It will be composed of patients from the Diabetes Outpatient Clinic of the Endocrinology Department at the Medical School of the University of São Paulo. Elderly subjects will be randomized into two groups (n = 20) who will undergo resistance training for 12 weeks, twice a week, and receive protein or placebo supplementation. Exercises will be performed for the large muscle groups: pectoral press, paddling, leg-press, extensor chair, gastrocnemius plantar flexions and abdominal crunches. Protein supplementation will be performed immediately after strength training by ingestion of 20 g of whey protein diluted in water. Also, immediately after training the placebo group will receive 20 g of maltodextrin diluted in water. All participants will be instructed to ingest 1.0 to 1.2 g of protein / kg of body weight per day. 24-hour food recall and food frequency questionnaires will be performed throughout the study. The following evaluations (before and after 12 weeks training) will be applied: Anthropometric: body mass, height, BMI and hip waist ratio. Functional evaluation through isokinetic dynamometry of knee extensors and flexors and a maximal repetition (1RM). Evaluation of body composition through Bioimpedance balance. Evaluation of food intake will be obtained by means of a 24-hour recall and food frequency questionnaire. All the evaluations will performed after 6 months. The training sessions will have a frequency of twice a week for 12 weeks. Eight exercises will be performed for the main muscle groups. In each exercise, 3 sets will be performed between 8 and 12 repetitions. The intensity should be between 7 - 8 and will be monitored according to Subjective Effort Perception using a scale of 0 to 10.

NCT ID: NCT03785301 Recruiting - Diabetes Mellitus Clinical Trials

Effect of FGM on Glucose Control in Diabetic Patients

Start date: December 20, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.

NCT ID: NCT03779139 Recruiting - Diabetes Mellitus Clinical Trials

Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis

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

Randomized pilot trial of patients (n=30) undergoing Total Pancreatectomy and Islet AutoTransplant (TPIAT). Patients with islet harvest of greater than 5000 islet equivalents/kg body weight will be randomized to receive a portion of their islets into an omental pouch. For outcomes related to islet function, a group of normal volunteers (n=15) will be studied as a comparator group.

NCT ID: NCT03777722 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Light and the Effect on Metabolic Syndrome and Alzheimer's Disease

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.

NCT ID: NCT03775057 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Use of the MyDose Coach Digital Tool for Self-titration of Insulin in Patients With Type 2 Diabetes

Start date: August 22, 2018
Phase: N/A
Study type: Interventional

Scientific studies show that the introduction of digital tools led to: Significant improvement in glycemic control, greater patient satisfaction, reduction of emotional burden, reduction of fear of hypoglycaemia, reduction of anxiety of the regimen, significantly fewer of additional visits to the doctor in addition to those scheduled and a reduction of resources. Primary Objective: To evaluate the efficacy and safety of the MyDose Coach digital tool in patients with T2D with basal insulin or candidates for the use of basal insulin. Secondary Objectives: Evaluate demographic variables and control variables (HbA1c, SMPG, FPG). Measure the units of insulin used before and after the intervention