Type 1 Diabetes Mellitus Clinical Trials – Overview
Type 1 diabetes mellitus is one of the commonest endocrine and metabolic disorders. It is a multisystem disorder characterized by persistent hyperglycemia which can manifest in the form of increased thirst, hunger, and frequent urination.
Diabetes also increases susceptibility to infection from bacteria and fungi. Diabetes has been classified into two major and other minor categories which are:
- Type 1 Diabetes Mellitus (Insulin Dependant DM)
- Type 2 Diabetes mellitus (Non-insulin Dependent DM)
- Other forms (Secondary DM, Gestational DM, Impaired glucose tolerance DM)
What is Type 1 Diabetes?
Type 1 Diabetes, also known as insulin-dependent diabetes, is a less frequently seen form of diabetes. It presents in a slightly different manner from Type 2 Diabetes.
Unlike Type 2 Diabetes which presents in older obese people, Type 1 Diabetes usually presents at a younger age and can affect people with normal body weight.
This is due to the difference in the underlying pathophysiology of Type 1 and Type 2 Diabetes.
While Type 2 Diabetes occurs due to increased insulin resistance in obese people, Type 1 Diabetes occurs due to a deficiency of insulin. In Type 1 Diabetes, the pancreas produces very low amounts of insulin that is insufficient to meet the body’s demand for insulin.
Insulin is essential to maintain normal blood glucose levels. Decreased insulin production can result in life-threatening hyperglycemia as the body can enter a state of ketosis.
Management of Type 1 Diabetes is difficult with oral hypoglycemic agents and patients usually require insulin replacement therapy to maintain their blood glucose levels.
There are many medications currently available for treating patients with Diabetes. However, these medications all have varying side effects. Even insulin replacement requires very careful titration to not overdose the patient as this may lead to fatal hypoglycemia.
Numerous studies are still being conducted to evaluate the best management strategies for diabetes, which we will discuss further in this article.
Type 1 Diabetes Mellitus Clinical Trials and Researches
1. Vitamin D and residual beta-cell function in type 1 DM
This study is being carried out to evaluate the role of vitamin D supplementation on type 1 diabetes in children who are on standardized insulin treatment.
In this trial, the participants on standardized insulin treatment will be divided into two groups. One group was given vitamin D (Ergocalciferol) and a placebo was given to the other group.
The effects of this will be studied to see if the long-term complications of type 1 DM are reduced among vitamin D users.
2. Islet Allotransplantation in Type 1 DM
The purpose of this study is to achieve insulin independence in patients with type 1 Diabetes.
This study is being carried out to see whether insulin independence can be achieved among those receiving islet transplantation in combination with an immunosuppressive regimen of cyclosporine and sirolimus.
3. Role of sirtuin-1 in Type 1 DM
Hypothetically, resveratrol is a drug that may improve both endothelin-B receptor and skeletal mitochondrial function in people with type 1 DM.
In this study, the participants will be grouped and one of those groups will be given Resveratrol twice daily for 12 weeks and another will be given a placebo. The effect of this will be studied to see improvement in endothelin and skeletal muscle mitochondrial function among those who had taken Resveratrol.
4. Tauroursodeoxycholic acid (TUDCA) in new-onset Type 1 DM
A study to evaluate whether slowing or preventing beta cell demise can prevent or improve the course of type 1 DM is currently underway.
The participants of this study will be divided randomly into two groups. One of the groups will get TUDCA whereas the other will receive a placebo.
This trial aims to evaluate whether endoplasmic reticulum stress will be reduced by TUDCA and this will, in turn, promote beta-cell survival in new-onset type 1 DM.
5. Safety, tolerability, and potential efficacy of AVT001 (Autologous Dendritic Cell therapy) in a patient with Type 1 DM
This is a double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of AVT001 and to assess it as a potential treatment of type 1 DM.
Among the participants, one group will be infused with AVT001 and the other will be infused with a placebo.
This trial will then be studied and compared for the safety, tolerability, and potential efficacy of AVT001 in the first group receiving AVT001.
6. Intravenous insulin vs subcutaneous insulin in intrapartum management of Type 1 DM
The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduce adverse outcomes associated with type 1 diabetes in pregnancy. Here, investigators are making comparisons between IV insulin and SC insulin therapy.
The participants of this study will be given IV and SC insulin randomly.
The participants will be observed and studied to determine which insulin therapy pathway results in minimum risk in intrapartum management of type 1 DM patients.
Davidson’s Principle and Practice of Medicine 23rd edition
Long cases in Clinical Medicine, JAYPEE publications