Innovative Clinical Trials Study New Treatments for Diabetes

Diabetes mellitus, known more commonly as diabetes refers to a group of metabolic disorders characterized by an increase in blood sugar level due to absolute or relative insulin deficiency. A chronic rise in blood sugar is associated with various long term complications. Insulin is a hormone secreted from your pancreas which keeps blood sugar in check.

Diabetes has two main types:
Type-1 Diabetes: Here your body’s immune system destroys beta cells of the pancreas (cells secreting insulin) leading to insulin deficiency and excess blood sugar.
Type-2 Diabetes: Here your pancreas does not produce enough insulin as required by the body or the cells in your body don’t respond to insulin (insulin resistance). Type -2 diabetes is more common than Type-1.

Risk Factors of Diabetes

The exact cause of Type-1 diabetes is not clearly known but it has shown to have familial preponderance, and certain viral infections are also associated including Rubella virus and Enterovirus. Also, these patients are shown to have diabetes auto-antibodies, cells that damage the pancreas.

The causes of Type 2 diabetes are also not known but some conditions which predispose you to it include:

• Obesity
• Sedentary lifestyle  
• Increasing Age
• Positive family history
• Blood pressure higher than 140/90 mm Hg

 

Signs and Symptoms of Diabetes

The symptoms of both diabetes are similar as both result in increased blood sugar levels though through different mechanisms. Some symptoms include:

• Increased thirst
• Increased urination
• Excessive hunger; predilection to sweet foods
• Unintentional loss of weight
• Bruises and cuts take a longer time to heal
• Increased susceptibility to infection 
• Getting ill often

The effects of hyperglycemia (excess blood sugar) are not immediately manifested and the damage can occur years before these symptoms occur so early recognition of symptoms can help get the disease under control quicker and prevent long-term damage.

Failing to control diabetes at the early stages can lead to long-term complications including damage to your eyes, kidney, and nerves. It can lead to stroke and various heart conditions. Long term diabetes may lead you to get your limbs amputated.

Diagnosing Diabetes

Diabetes is diagnosed after a thorough medical history followed by blood tests and urine tests. If you have 2 or more of the above-mentioned features you should consult your practitioner as soon as possible to curb the disease early in its course.

• Blood Test: To assess serum glucose levels ((fasting glucose greater than 126 mg/dL (< 100 mg/dl), random glucose over 200 mg/dL (<140 mg/dl) or glycosylated hemoglobin (HbA1c) level exceeding 6.5% (<5.7%) is suggestive of diabetes). Fasting glucose levels and HbA1c testing are useful for the early identification of T2DM.
• Urine Test: To check for the presence of excess glucose and ketone bodies in urine.
• Antibody tests: To check for the presence of auto-antibodies destroying beta cells of the pancreas.
• Oral glucose tolerance helps to diagnose pre-diabetes, a condition that often precedes Type 2 Diabetes. This test measures your body’s response to glucose. It involves taking a glucose solution containing 75 gm of sugar and assessing your blood sugar level after 2 hours.

 

Managing Diabetes

Proper diet and lifestyle modification can go a long way in preventing complications and keeping diabetes in control but most times you will need medicine to control diabetes. Various classes of anti-diabetic (hypoglycemic) drugs help in control which can be given orally or should be injected.

• Metformin (Biguanides): Metformin is the drug of choice in treating Type-2 diabetes, it controls blood sugar by decreasing blood glucose production from the liver and increasing uptake from parts of your body by regulating various metabolic processes in the body.
• Sulfonylureas: This oral group of drugs helps counteract diabetes by increasing insulin production from the pancreas. It also promotes weight gain and prevents microvascular complications (affecting small blood vessels) of diabetes.
• Meglitinides: This group of the drug too has a pancreas stimulating effect for insulin production but is more fast-acting. A sudden drop in blood sugar is a recognized complication.
• Sodium and Glucose Transport inhibitors: Drugs of class SGLT-2 inhibitors are taken through injections and prevent kidneys from re-up taking sugar into the blood and promotes its excretion through urine. In addition to diabetes control, it helps reduce the risk of stroke and heart attack.
• Insulin preparations: Given subcutaneously or intravenously during an emergency. Most people with Diabetes-1 require multiple insulin shots in a day whereas in type 2 diabetes long-acting insulin is used as a single dose ) or in combination with an oral hypoglycemic. Twice daily administration of short-acting and intermediate-acting insulin before morning and evening meals is also a common regimen.

Other groups of drugs are too used but these drugs have shown only mild to moderate efficacy in treating diabetes and serious side effects.  

Treatment Modalities Currently Undergoing Clinical Trials

Treatment methods are being improvised and new modalities being tried to provide effective and safe treatment for diabetes.

• Faster Acting Insulin (Fiasp): A study is being conducted to determine the effects of faster-acting insulin, Fiasp on blood sugars after meals in hospitalized patients with Type-2 diabetes in comparison to multiple doses of another type of insulin Novolog. This study currently in the third stage of its trial aims at finding a better solution for achieving good blood sugar control in hospitalized patients.
• Pancreatic Islets and Parathyroid Gland Co-transplantation: Currently under the second stage of the trial this aims at bringing insulin independence in people with Type-1 diabetes by grafting pancreatic islets and parathyroid gland from another healthy person (allograft). 
• Functional Medicine: The benefits of the functional medicine approach in the treatment of diabetes are being studied in comparison to the usual care approach with insulin therapy. This approach aims at identifying and treating underlying causes thus preventing cases of diabetes. There could be a significant reduction in the disease burden and health care costs associated with the disease if this method proves effective.
• Iv Ig: Treatment-induced neuropathy (presenting with numbness and weakness) is a known complication during diabetes control. The effectiveness of intravenous immunoglobin is being studied for its effectiveness in counteracting this problem and ensures better patient compliance with treatment. It is currently in the second stage of the trial.
• Repeat BCG: The benefits of repeat BCG vaccination (vaccine to prevent TB) currently on the second stage of the trial is being studied for the treatment of established cases of Type-1 diabetes. Phase 1 result of the study showed the death of certain disease-causing white cells and small restoration of pancreatic insulin.
• Metabolic analysis for treatment of Gestational Diabetes: Gestational diabetes is a source of a large number of maternal and infant mortality worldwide. A study is being conducted which aims at finding the best treatment based on which diabetes developed in pregnant mothers. It is currently in the fourth stage of the trial. 

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1. Amit Sapra, Priyanka Bhandari et al. Diabetes Mellitus. : StatPearls Publishing; 2020 Jan-.( https://www.ncbi.nlm.nih.gov/books/NBK551501/)
2. Akram T Kharroubi, Hisham M Darwish et al. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25; 6(6): 850–867.( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4478580/)
3. A. Ramachandran et al. Know the signs and symptoms of diabetes. Indian J Med Res. 2014 Nov; 140(5): 579–581( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4311308/)

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