Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Homeostatic Model Assessment of Insulin Resistance
研究概览
简要总结
In addition to its effect on maintaining calcium homeostasis and mineralization of bone, vitamin D has been linked to play a pivotal role in different medical conditions including type 2 diabetes mellitus. Vitamin D plays a major role in both insulin secretion and decreasing the insulin resistance hence has a major impact on glucose tolerance. This study is designed to determine the non-skeletal effects of vitamin D in improving the glucose tolerance in type 2 diabetic patients by decreasing the insulin resistance
详细描述
Pakistan stands at seventh spot amongst the world having patients suffering from Type 2 Diabetes Mellitus (T2DM) with the prevalence of approximately 6.9 million in 2007.
Among the risk factors for the development of T2DM, there is a growing evidence that deficiency of vitamin D is an independent risk factor for its development and poor glycemic control. Vitamin D plays a significant role not only in secretion of insulin from the beta cells of pancreas but it also helps in decreasing the insulin resistance at the level of target cells.
Vitamin D has received an enormous attention recently. A report from Australia indicated 1 in 3 Australians are Vitamin D deficient. Reports from Pakistan have also demonstrated Vitamin D deficiency. The study conducted by Haroon Khan et al had 562 (76.2%) females while 175 (23.8%) were males. Mean age of respondents was 36.3 years (age range 15-75 years. Females had significantly lower mean Vitamin D levels (56.2%) compared to males (15.3%).
25(OH) Vitamin D is the circulating form of vitamin D which is measurable in the blood. Vitamin D insufficiency has been defined as serum 25-hydroxyvitamin D (25(OH) D) levels below 30 ng/mL and it is common among patients with T2DM. Many studies have revealed that Vitamin D3 (calcitriol) has a role in the synthesis and the secretion of insulin by receptor mediated molecular mechanisms.
Moreover Vitamin D functions are not limited to skeletal health benefits and may extend to preservation of insulin secretion and insulin sensitivity. Studies have revealed the association between vitamin D deficiency and changes in blood glucose and insulin levels as well as sensitivity of the target tissues to insulin .Cross-sectional data provide some evidence that circulating 25-hydroxyvitamin D (25(OH) D) is inversely associated with insulin resistance, although direct measurements of insulin sensitivity are required for confirmation. Available prospective studies support a protective influence of high 25(OH) D concentrations on type 2 diabetes mellitus risk. Vitamin D receptor gene polymorphisms and vitamin D interactions with the insulin like growth factor system may further influence glucose homeostasis. The ambiguity of optimal vitamin D dosing regimens and optimal therapeutic concentrations of serum 25(OH) D limit available intervention studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Age 25 to 50 years as type 2 diabetes usually diagnosed in this age range.
- •Patients having Type 2 Diabetes Mellitus
- •Taking oral antidiabetic medicines
- •Serum 25(OH) vitamin D levels below 20ng/ml having no clinical symptoms of vitamin D deficiency.
- •HOMA-IR > 2.5
排除标准
- •Patients having evidence of liver dysfunction and chronic renal insufficiency because it will alter the metabolism of cholecalciferol.
- •Patients having parathyroid dysfunction diagnosed on the basis of blood tests as replacement of vitamin D in these patients is very complex.
- •Patients having gastrointestinal surgeries that will alter the absorption of cholecalciferol diagnosed from detailed clinical history and clinical examination.
- •Patients having clinical features of gastroparesis diagnosed on the basis of clinical history as it can alter the absorption of vitamin D.
- •Patients having erratic control of diabetes requiring multiple hospital admissions for diabetic emergencies.
- •Pregnant and lactating mothers.
研究组 & 干预措施
vitamin D
vitamin D arm will receive oral vitamin D in escalating dosage.
干预措施: oral vitamin D (Drug)
结局指标
主要结局
Homeostatic Model Assessment of Insulin Resistance
时间窗: 3 months
insulin resistance reduction to \<2.5
次要结局
- Glycated Hemoglobin (HbA1C)(3 months)
研究者
Fawad Ahmad Randhawa
Assistant Professor of Endocrinology
King Edward Medical University
