25 in progress, 13 open to eligible the 1 last update 14 Jul 2020 people 25 in progress, 13 open to eligible people
(R33 Phase) Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
open to eligible people ages 18 years and up
We plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM) will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate restricted diet for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI).
San Francisco, for 1 last update 14 Jul 2020 CaliforniaCalifornia
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
open to eligible people ages 19 years and up
reverses diabetes type 2 questions (👍 insulin dependent) | reverses diabetes type 2 menu diethow to reverses diabetes type 2 for This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.
San Francisco, California
Diabetes and Depression Text Messaging Intervention
open to eligible people ages 18-75
The main aim of the "" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. a static messaging intervention with health management and educational messages and 2. a control condition that receives a weekly mood message. The primary outcomes for this aim will be improvements in physical activity at 6-month follow-up defined by daily step counts.
San Francisco, California
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
open to eligible people ages 18-40
TThe study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.
San Francisco, California and other locations
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
open to eligible the 1 last update 14 Jul 2020 people ages 3 years and up open to eligible people ages 3 years and up
The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive the 1 last update 14 Jul 2020 hydroxychloroquine or placebo and close monitoring for progression of T1D.The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.
San for 1 last update 14 Jul 2020 FranciscoSan Francisco, California and other locations
Inflammation, Diabetes, Ethnicity and Obesity Cohort
open to eligible people ages 25-65
Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time. In this proposed study, investigators will recruit subjects from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area.
San Francisco, California
Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes
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The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.
San Francisco, California
Progression and Etiology of Cortical Porosity in Diabetic Bone Disease
open to eligible people ages 50-70
reverses diabetes type 2 mellitus nature reviews disease primers (☑ questions for dr) | reverses diabetes type 2 nicehow to reverses diabetes type 2 for Type 2 diabetes is associated with increased cortical bone porosity and increased the 1 last update 14 Jul 2020 fracture risk. The goal of this proposed study is to understand the longitudinal evolution of cortical bone porosity and to investigate the underlying biological processes that drive increased cortical porosity and fracture risk in the setting of diabetes. The investigators will apply novel techniques for in vivo imaging of cortical pores to patients with type 2 diabetes and controls in a longitudinal prospective study. This work will establish the longitudinal progression of cortical porosity and determine whether pore content can serve as a predictor of future cortical degradation and bone fragility.Type 2 diabetes is associated with increased cortical bone porosity and increased fracture risk. The goal of this proposed study is to understand the longitudinal evolution of cortical bone porosity and to investigate the underlying biological processes that drive increased cortical porosity and fracture risk in the setting of diabetes. The investigators will apply novel techniques for in vivo imaging of cortical pores to patients with type 2 diabetes and controls in a longitudinal prospective study. This work will establish the longitudinal progression of cortical porosity and determine whether pore content can serve as a predictor of future cortical degradation and bone fragility.
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Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes
open to eligible people ages 8 years and up
The study is a clinical trial testing sequential therapy with rituximab followed by abatacept in individuals destined to develop clinical type 1 diabetes.
San Francisco, California and other locations
Study to Understand Gaining Access to Blood Glucose Records
open to eligible people ages 18 years and up
This study is a two-arm randomized controlled trial in which participants will receive either the Livongo Health system or iHealth glucose meter for measuring their blood glucose. The study hypothesizes the use of the Livongo Health system results in a greater improvement in A1c compared to standard blood glucose monitoring, as demonstrated by the iHealth Bluetooth-enabled glucose meter.
San Francisco, California
Treatment of Type I Diabetes by Islet Transplantation Into the Gastric Submucosa Study Protocol
open to eligible people ages 18-70
The goal of this trial is to gain initial clinical experience regarding the safety and efficacy of treating type I diabetes in people who have received a kidney transplant by transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa). A total of 6 patients will be enrolled in the study and followed for a period of up to 3 years after the last islet transplant.
San Francisco, California
TrialNet Pathway to Prevention of T1D
open to eligible people ages 30 months to 45 years
Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.
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Type 1 Diabetes Extension Study
open to eligible people ages 8-35
To further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov records NCT00129259 and NCT00965458).
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A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
Sorry, in progress, not accepting new patients
The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
San Francisco, California and other locations
A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D)
the 1 last update 14 Jul 2020 Sorry, Sorry, in progress, not accepting new patients
The purpose of this study is to assess the safety and tolerability for 1 last update 14 Jul 2020 of different doses of AG019 administered alone or in combination with teplizumab in participants who recently developed Type 1 Diabetes Mellitus (T1D).The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants who recently developed Type 1 Diabetes Mellitus (T1D).
San Francisco, California and other locations
CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1
Sorry, in progress, not accepting new patients
The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of AGT or T1DM. Subjects will for 1 last update 14 Jul 2020 receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM. Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM. Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.
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Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
the 1 last update 14 Jul 2020 FresnoFresno, California and other locations
Enhancing Self-Management Support in Diabetes Through Patient Engagement
Sorry, accepting new patients by invitation only
The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care. SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care. To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.
San the 1 last update 14 Jul 2020 Francisco, California San Francisco, California
Low-dose IL-2 in Established T1D - The "PROREG" Study
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Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further loss of beta-cell function in patients with established T1D, (primary outcome). The study will carefully examine various effects of low-dose IL-2 on the immune system in patients with T1D, including effects on Treg and other cell subsets, and disease-specific autoimmune responses.
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Sorry, in progress, not accepting new patients
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
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Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
Sorry, in progress, not accepting new patients
This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.
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T1DM Immunotherapy Using Polyclonal Tregs + IL-2
Sorry, in progress, not accepting new patients
The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.
San Francisco, California and other locations
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Sorry, in progress, not accepting new patients
The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "" state and thereby prevent or delay the onset of type 1 diabetes.
San Francisco, for 1 last update 14 Jul 2020 CaliforniaCalifornia and other locations
The Impact of Diabetes on REvascularization
Sorry, in progress, not accepting new patients
The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascularization has determined the effect of diabetes on mechanism of revascularization failure. Therefore, this trial represents a unique opportunity to investigate the mechanisms by which diabetes affects surgical and endovascular revascularization procedures with the long-term goal of improving outcomes in CLI.
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Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Sorry, in progress, not accepting new patients
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control. Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.
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