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临床试验/NCT02098980
NCT02098980Unknown不适用

Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar

Supreme Council Of Health, Qatar1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Insulin Resistance

研究概览

简要总结

There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will decrease insulin resistance and the associated metabolic indices linked to the later development of T2DM.

详细描述

Epidemiologically, there is an association between elevated T2DM risk and low serum levels of vitamin D and suggest that it may protect against the diseases through the improvement of insulin sensitivity as well as secretion and reducing chronic inflammation. Although some of these effects were shown in clinical studies, no study permitted the inference that vitamin D can reduce blood glucose and attenuate inflammation. Post-prandial glucose is the most sensitive to alterations in insulin sensitivity. Therefore, it is rational to examine whether vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM and to elucidate the mechanism by which this occurs, i.e. via improved insulin sensitivity or improved insulin secretion, or both. Furthermore, identifying a distinct proteomics-based signature that can be used to distinguish responders to supplementation from non-responders is critical to define the bases for inter-individual variation in response and the effect of vitamin D on the prevention of T2DM. Identification of this proteomics-based signature will enable us to tailor alternative preventive measures to adjust the vitamin D dose to non-responders, leading to more effective and precise intervention protocols.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or non-pregnant, non-lactating females, aged 18-75
  • volunteered to participate by signing the consent form
  • BMI ˂ 40kg/ m2
  • serum 25(OH) vitamin D3 (25(OH)D) concentration ˂75nmol/L
  • fasting serum glucose <7.0 mmol/L
  • HOMA insulin resistance index ≥1.3
  • presence of any ONE OR MORE of the following risk factors for type 2 diabetes:
  • high BMI (>23)
  • high waist circumference according to IDF ethnic specific values for non- Caucasian (females >80cm; males >90cm)
  • family history of diabetes in first-degree relative (parent or sibling)
  • previous history of gestational diabetes
  • history of high blood glucose, high triglycerides and/or low HDL cholesterol

排除标准

  • fasting serum glucose ≥7.0mmol/L
  • history of renal failure or liver disease
  • serum urea or creatinine >1.8 times upper limit of normal (ULN)
  • serum aspartate or alanine transaminase (AST,ALT) >1.5 times ULN
  • current use of drug or drugs to treat diabetes or which influence glucose metabolism
  • medical or surgical event requiring hospitalization within 3 months of randomization
  • presence of any condition affecting nutrient absorption

结局指标

主要结局

Insulin Resistance

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Supreme Council Of Health, Qatar
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Al Thani

Doctor

Supreme Council Of Health, Qatar

研究点 (1)

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