Study the effect of vitamin D3 and vitamin C on glycemic control and oxidative stress markers in Type-2 Diabetes mellitus patients.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2021/03/032373
- Lead Sponsor
- Shingare Sujata Prakash
- Brief Summary
Diabetes mellitus (DM) refers to a group of common metabolic disordersthat share the phenotype of hyperglycemia. Several distinct types of DMare caused by a complex interaction of genetics and environmental factors.Depending on the etiology of the DM, factors contributing tohyperglycemia include reduced insulin secretion, decreased glucoseutilization, and increased glucose production. The metabolic dysregulationassociated with DM causes secondary pathophysiologic changes inmultiple organ systems that impose a tremendous burden on theindividual with diabetes and on the health care system.¹Type 2 diabetes mellitus (T2DM) is a complex disorder influenced by bothgenetic and environmental factors. It is characterized by chronichyperglycemia, altered insulin secretion, and insulin resistance.² As inmany western countries, T2DM is associated with increased morbidity andmortality due to microvascular (e.g. Retinopathy, Neuropathy andNephropathy) and macrovascular (Myocardial infarction, Peripheralvascular disease, Stroke ) complications.²Current evidence has demonstrated that oxidative stress plays animportant role in the pathogenesis of chronic diseases such as DM andmay diminish the antioxidative defense system of the body, increasing theoxidative load.³ The damaging effects of oxidative stress are mainly causedby the production of free radicals of oxygen and reactive oxygen species(ROS).³ It is believed that diabetes is associated with increased oxidativestress because of increased blood concentrations of thiobarbituric acidreactive substances and serum malondialdehyde, the end products of lipidperoxidation.³Lowering glycated heamoglobin (HbAâ‚c) to below 7% has been shown oneof the primary endpoints in reducing microvascular complications ofdiabetes mellitus and possibly macrovascular disease.³â»â´Although therapies for T2DM and its co-morbidity have improved over thelast few decades, the need for new insights for the prevention andmanagement of T2DM remains needed due to the increased impact of thedisease.âµThere is accumulating evidence suggesting that vitamin D status plays arole in many non-skeletal functions including diabetes mellitus.âµVitamin D deficiency appears to be related to the development of diabetesmellitus type 2.â¶Renewed interest in vitamin D, the so-called “sunshine vitamin,†hasoccurred recently because it has been linked to everything from cancerand heart disease to diabetes.â·There is growing evidence that vitamin D deficiency could be acontributing factor in the development of both type 1 and type2 diabetes.First, the β-cell in the pancreas that secretes insulin has been shown tocontain VDRs as well as the 1 alpha hydroxylase enzyme.â·Vitamin D was found to be involved in maintenance of glucosehomeostasis through numerous mechanisms connected with the insulinsignaling pathway. Vitamin D takes part in sustaining of normal level ofCa2+ and reactive oxygen species (ROS) both in pancreatic beta cells andinsulin responsive cells.â¸Vitamin D is required for and improves the production of insulin, and alsoimproves insulin sensitivity.â¹D3 can be combined with Vitamin D3 receptor on the islet β cells,increasing insulin sensitivity, inhibiting inflammatory factors, alleviatingchronic inflammation process of the pancreas to improve the function ofislet β cells ; Additionally, it also inhibits the action of therenin-angiotensin system, which promotes insulin secretion . Vitamin Dsupplementation can improve islet β cell function and glucose tolerance.¹â°It regulates adipogenesis during adipocyte differentiation, stimulatesinsulin synthesis, protects pancreatic B cells and decreases insulinresistance in muscles.¹¹Studies have shown that vitamin D deficiency is associated with thedevelopment of T2D, T2D nephropathy, T2D microvascular ormacrovascular disease, diabetic retinopathy, and diabetic peripheralneuropathy.¹²â»Â¹Â³In addition, diabetes mellitus (DM) and chronic kidney disease (CKD) arealso related to vitamin D levels, vitamin D influences the renin-angiotensinsystem, inflammation, and mineral bone disease, which may be associatedwith the cause and progression CKD.¹â´It has been revealed that vitamin D plays an important role in reducinginflammation and controlling immune activation.¹âµOxidative stress plays a central role in the onset of diabetes mellitus aswell as in the development of vascular and neurological complications ofthe disease. ¹â¶Consumption of antioxidants nutrients, chiefly vitamin C and E seems todecrease oxidative injury associated with hyperglycemia and pancreatic βcell function and reduces the prevalence of diabetic complications.¹ⶠROSare involved both in insulin signal transduction and in insulin resistancewhen produced in excess.¹â¶Vitamin C, also known as ascorbic acid, is a cofactor in multiple enzymaticreactions including collagen synthesis. Vitamin C acts as a reducing agentin free radical-mediated oxidation processes; therefore, it can act as anantioxidant.¹â·Vitamin C is structurally similar to glucose and can replace it in manychemical reactions and thus is effective for prevention of non-enzymatic glycosylation of protein.¹⸠Ascorbic acid (vitamin C), an antioxidant vitamin,plays an important role in protecting free radical-induced damage.¹â¸Antioxidant treatment has beneficial effects on preservation of β cellfunction in diabetes.¹â¸Diabetes mellitus is a major health problem with serious and severecomplications, therefore, in order to improve management and outcome,we have designed this study to evaluate if the administration of vitamin Dand vitamin C improves glycemic control as well as reduces complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 96
- Male and female patients between 30-75yrs of age, diagnosed with type-2 diabetes mellitus within last 1 year of collection of data.
- Receiving oral anti-diabetic medications but does not need insulin within last 1 year i.e. from the date of diagnosis of type-2 diabetes mellitus.
- Patients with HbA1c value more >7% and <9% despite therapy.
- DM other than T2DM.
- Patients with abnormal liver function tests.
- Patients with cardiovascular or respiratory insufficiency.
- Acutely ill patients.
- Pregnant and nursing women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study will be reduction in HbAâ‚c, reduction in HbAâ‚c during the period from day 0 to day 90 which is the primary measure of glycaemic control. reduction in HbAâ‚c during the period from day 0 to day 90
- Secondary Outcome Measures
Name Time Method The secondary outcomes will be decrease in oxidative stress and thereby decrease in the development of complications in
Trial Locations
- Locations (1)
BJGMC and Sassoon hospital
🇮🇳Pune, MAHARASHTRA, India
BJGMC and Sassoon hospital🇮🇳Pune, MAHARASHTRA, IndiaSHINGARE SUJATA PRAKASHPrincipal investigator8600833063shingaresujata@gmail.com