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临床试验/NCT04183257
NCT04183257已完成4 期

Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics

King Edward Medical University0 个研究点目标入组 106 人开始时间: 2016年9月30日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fawad Ahmad Randhawa

Assistant Professor of Endocrinology

King Edward Medical University

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