This trial is evaluating whether Treatment will improve 1 primary outcome, 5 secondary outcomes, and 1 other outcome in patients with Diabetes, Autoimmune. Measurement will happen over the course of up to 70 days.
This trial requires 80 total participants across 2 different treatment groups
This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.
It is very common for diabetes patients to be treated with anti-diabetic medications, to undergo oral glucose tolerance testing, and to have a screening eye examination.
The American Diabetes Association estimates approximately 90 million Americans will be diagnosed with diabetes by the age of 30 in 2025. The ADA's annual report, "Diabetes: the National Healthcare Plan" illustrates the increasing health impact of this disease.
Diabetic retinopathy is the most common sight-threatening complication in diabetes (8.3 million/yr) and appears to be related to early atherosclerosis (0.4-3.1 million/yr) and autoimmunity (0.7-1.1 million/yr) of the eye (Ozumaki C, J Pediatr Ophthalmol 21, 1165-76).
Autoimmune and genetic factors play a role in developing diabetes, but further work is required. Diabetes mellitus is an autoimmune disease involving immunological reactions to beta adrenergic receptors.
Diagnosis of diabetes can be difficult because it is not a straightforward issue. Symptoms such as an increased frequency and severity of glycemic values are often the first signs to appear. It is also possible that patients might present with a family history of diabetes. Symptoms that indicate diabetes, autoimmune, or other diseases need to be further investigated to make a proper diagnosis.
Diabetics are more likely to be diagnosed with autoimmune conditions than nondiabetics, perhaps because there's a greater awareness of autoimmune conditions among diabetics. Autoimmunity could be a marker for an increased risk for developing chronic and disabling complications. However, in older children and adults with diabetes, there is no significant difference in the incidence of autoimmune conditions, as compared with nondiabetics. So when considering immunosuppressive therapy, this factor cannot be ignored.
Significant improvements in overall HRQOL and in several aspects of HRQOL are achievable with treatment of patients with diabetes and autoimmune disorders using an evidence-based approach.
The clinical features of each of these four conditions (i.e., thyroid disease, autoimmune thyroid disease, type 1 diabetes, and type 2 diabetes) are very similar and most importantly not very different from one another. Type 1 and type 2 diabetes in particular should be treated as variants of a unique entity based on clinical similarity rather than differences in clinical presentation. This means that treatments that are normally directed at either type 1 diabetes or type 2 diabetes may be just as effective at treating either form of the disease.
Treatment with conventional antidiabetics and aspirin was superior to treatment with placebo. Results from a recent paper are discussed with regard to their mechanisms of action in addition to the possibility of a direct effect of the agents examined, while not excluding the possibility of a non-specific effect of the agents.
For many new-onset autoimmune diseases, the risks and benefits of treatment are uncertain. Treatments might be considered for all patients if benefit outweighs risk, but many patients with autoimmune disease would never be eligible for treatment.
Diabetic complications are more prevalent among those with autoimmune or inflammatory diseases than in those without them, and diabetes associated with autoimmune diseases is found more often in women.
Diabetes-related autoimmunity in females is not as [severe] as in males. In females, autoimmune [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) is rare, and [in this study] type 2 diabetes is rarer. The prevalence of diabetic retinopathy is higher in females than in males, and the percentage of diabetics getting sight loss is not so high. Thus, female diabetes patients are healthier and less likely to end up with sight loss than the male counterparts. But the seriousness of diabetes and diabetes-related autoimmunity cannot be forgotten.