Active clinical trials for "Diabetes Mellitus, Type 1"

The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

Diabetes, recently declared a pandemic by the World Health Organization, is a risk factor for increased mortality and morbidity. Its multi-functional complications, in the short and long term, are a serious problems for the global public health. Millions of patients, the world over, suffer Diabetes, a chronic and degenerative disease without treatments today. America, and particularly the Caribbean and Central America Region, is seriously affected despite the efforts of the Public Health Systems. Caribbean Region presented nearly twice the incidence and prevalence of type 1 and type 2 diabetes when compared with the rest of the Americas. Today stem cells are emerging as a valid alternative of treatment. In vitro experiments with adult stem cells demonstrated their ability to migrate and differentiate into cells of different lineages. The bone marrow stem cells are safe, effective and have a lot of scientific evidence that supports the carrying out of clinical research in phases II and III. Our protocol is an Autologous Bone Marrow Stem Cell Transplantation, without immune suppression or cell cultures. Our hypothesis is that the stem cells will act as immune modulators, angiogenic and in a regenerative way stimulating quiescent stem cells and improving the metabolic control by endogenous secretion of insulin.

Type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. Motivational Interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity. Our objective is to evaluate the impact of an intervention with Motivational Interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. At least sixty patients with type 1 diabetes will be included with HbA1c> 8% that will be randomized with a ratio of 1: 1. In the intervention group, Motivational Interviewing will be applied in the routine clinical appointments with the Endocrinologist, while the control group will receive the same visits but in a traditional way. The primary result will be self-care behaviors according to a validated questionnaire. Secondary outcomes include: HbA1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure. The professionals will be trained in Motivational Interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. They will also be evaluated through a specific questionnaire.

Approximately 80 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms:diabetes diet+highland barley diet; or diabetes diet. Study treatment will continue for 12 weeks. The primary efficacy measure is the change in MAGE from continuous glucose monitoring system at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 8-day run-in period (period B) and a 12-week treatment period (period C). Continuous glucose monitoring system will be used in baseline and endpoint.

Increasing evidences suggest that infections are important etiological factors for the development of Type 1 Diabetes (T1D). The overall hypothesis of the study is that the treatment of children, during the first year after diagnosis of T1D with Azithromycin, combined with repeated episodes of intensified insulin treatment to induce maximal beta-cell rest, and dietician support to promote dietary habits that minimize the likelihood of bacterial reflux from the duodenum to the pancreatic duct, will lead to preservation of beta cell function. This trial will examine whether the AIDIT protocol initiated within one week from diagnosis could preserve insulin production in children with Type 1 Diabetes.

Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months

Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulation and improving regeneration. Study design and method: In a Triple blinded randomized placebo-controlled phase I/II clinical trial, 20 patients with newly diagnosed type-1 diabetes who would be visited in Children's Growth and Development Research Center of Tehran University of Medical Sciences and Royan Institute Cell Therapy Center, would be assessed through two groups including the case group and the placebo group. Participants: Patients of both sexes in a range of 8 to 40 years old who have been diagnosed to have type-1 diabetes in no more than 6 weeks, antibody against beta cells diagnosed in their blood, fasting c-peptide more than or equal to 0.3 ng/ml, and are not suffered from other acute or chronic diseases and cancers, would be studied. Interventions: Intravascular transplantation of autologous mesenchymal stem cells in the case group; placebo injection in the control group. Outcome variables: safety and efficacy.

The purpose of this study is to investigate if a diet high in plant protein improves kidney function in patients with kidney insufficiency and diabetes and/or hypertension and/or glomerulonephritis. The study is a non-blinded, randomized, controlled, cross-over-design with two intervention periods of each 14 days. Between the two interventions periods there is a washout period of 14 days. The participants are randomized to start with an individualized diet plan containing either high amounts of animal protein or high amounts of plant protein.

Stem Cell Educator (SCE) therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SCs) in vitro, and returns only the "educated" autologous immune cells to the patient's circulation. Several mechanistic studies with clinical samples and animal models have demonstrated the proof of concept and clinical safety of SCE therapy. They suggest SCE therapy may function via CB-SC induction of immune tolerance in the autoimmune T cells and pathogenic monocytes/macrophages when these are exposed to the autoimmune regulator protein (AIRE) in the CB-SCs. In this project, the optimized SCE therapy for type 1 diabetes (T1D) and T2D will be tested in a prospective, single-arm, open-label, single-center study to assess its clinical efficacy and related molecular mechanisms in patients with diabetes.

The CLIMATE Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific efforts, somatosensory amplification, self-efficacy, health literacy and commitment to the GP, degree of urbanisation of the patients' administration district and characteristics of the patients' neighborhood are associated with these effects.