View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell autoimmunity as indicated by positive islet autoantibodies.
This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.
One in three people will be diagnosed with diabetes by 2050, and the proportion will likely be higher among Native Americans. Diabetes control is currently suboptimal in underserved populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is a key determinant of diabetes control, but such empowerment can be difficult to achieve due to resource limitation and cultural, language and health literacy barriers. The investigators will conduct a home-based chronic disease (diabetes) educational intervention using Community Health Representatives (CHRs) to associate improvement in Patient Activation Measures scores (primary outcome) and clinical indicators of diabetes control (secondary outcomes).
This study aims to achieve more accurate early classification of diabetes and identification of which patients will rapidly require insulin treatment. The investigators will recruit 1000 participants who have been diagnosed with diabetes in the last year and were aged between 18 and 50 years at the time of diagnosis. The investigators will recruit an additional cohort of 400 participants diagnosed after age 50 treated with insulin at recruitment. The investigators will record clinical features and biomarkers that may help us to determine diabetes type at diagnosis and follow participants for 3 years to assess the development of severe insulin deficiency (measured using C-peptide) and insulin requirement. The investigators will assess utility of clinical features and additional biomarkers in identifying patients with rapid progression to insulin requirement. Findings will be integrated into a freely available clinical prediction model.
This is a 3-year prospective randomized comparative study of the efficacy of patient navigation on health education, health related quality of life, healthcare utilization, and medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the patient-navigator intervention or to a care-as-usual control condition. A total of 300 recently incarcerated individuals will be enrolled with 150 subjects each in the intervention and usual care group. The investigators hypothesize that the intervention will improve health education, health related quality of life, adherence to clinical appointments, glycemic/blood pressure control, and virologic suppression in HIV-infected. The results of this study will demonstrate interventions to eliminate health disparities in a highly marginalized group going through the transitional phase of re-entry into the community.
This clinical trial studies the physiology and immunology of new-onset post-transplant diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose tolerance testing (OGTT), euglycemic hyperinsulinemic clamps, and immune assays will be used to define the mechanisms associated with abnormal glucose homeostasis following stem cell transplantation. Information from this clinical trial could be used to develop standardized screening procedures or to develop optimal treatment strategies for patients developing post-transplant diabetes mellitus.
The TRACK [Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P. Cipriani (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of L'Aquila, L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A., joint erosion and cartilage destruction.(1) Anakinra (a recombinant form of the naturally occurring IL-1 receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and IL-1β) has shown in a number of RCTs (2-6) to be effective in the treatment of R.A., in monotherapy,(2,4) as well as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an important role in the pathogenesis of T2D: Glucose has been shown to induce IL-1β hypersecretion through inflammasome activation, while IL-1β induces impairment of β-cell secretory function and β-cell apoptosis.(7) In prediabetic subjects, the expression of IL-1Ra is induced by IL-1β and reflects the body's response to counterbalance increased IL-1β activity.(7) Levels of IL-1Ra tend to rise up to 6 years before the diagnosis of T2D.(8,9) IL-1Ra has been successfully used as a marker for the risk of developing T2D in subjects with metabolic syndrome.(10) As a clinical proof of concept, IL-1 inhibition with anakinra in patients with T2D has shown to improve the secretorial function of beta-cells as well as to lower the ratio of proinsulin/insulin and glycated hemoglobin/hemoglobin significantly, favoring glycemic control and possibly reducing the severity and prevalence of the associated complications of this disease.(11) Summarizing, IL-1 inhibition with anakinra has a clinical impact on R.A. as well as T2D. As from 6-10% of Italian R.A. patients have also T2D, this trial aims at investigating the impact of IL-1 inhibition on both diseases. Very recent data also show that T2D is a predictor of response to anakinra-treatment in R.A. patients,(12) which furthermore justifies the use of anakinra in this subset of R.A. patients. Objectives: [Primary] To evaluate the change in HbA1c between baseline, 3 months, 6 months, 1 year and at last follow up of 2 years from the beginning; [Secondary] To evaluate the efficacy on controlling signs & symptoms of R.A., assessing the remission rate at 3 months, 6 months, 1 year and at follow up (2 years), using the evaluation scale of disease activity on 28 joints, DAS28 and SDAI improvements from baseline conditions over time points, according to EULAR response criteria. Methods: 200 patients in 28 Italian centers with active R.A. refractory to treatment with methotrexate and T2D will be enrolled and randomized to receive either 100mg of anakinra once daily by subcutaneous injection or any anti-TNF-alfa drug treatment. [84 subjects will be required in each treatment arm to reach 90% power with an alpha error of 0.05 to detect a mean difference between the study arms of 0.25 percentage points of HbA1c . The assumed difference of HbA1c is rather conservative when compared to previously published changes in T2D patients (11).] Anti-diabetic treatment is required to be unchanged for at least one month prior to enrolment. Patients will be invited to maintain dietary habits and lifestyle during the study period. Further details can be viewed on the trials website after subscription.(13) References: (1) Arend & Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan, Arthritis Rheum. 1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4) Nuki, Arthritis. Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen, Rheumatology 2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder, Diabetes Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola, J. Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12) Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/ Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to the Italian law decree 17 December 2004. (B) speaker fees
Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown that glucose present in the fluid in the front of the eye, called the aqueous humor, correlates well with blood glucose. As blood glucose changes, the optical properties of the aqueous humor change, causing a change in the appearance of the iris of the eye.. The data collected in this study will be shared with IRISense to assist in validating the algorithm being used to develop the database needed. The data collected so far is in a narrow band of the normal glycemic range (healthy volunteers). We will collect standard digital photographic images of the eyes of subjects with diabetes along with corresponding blood glucose concentrations using the finger stick glucose monitoring method. In order to do this we will use standard digital photography techniques that is embedded in our benchtop prototype device