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临床试验/NCT02027740
NCT02027740已完成不适用

Effect of Almond Supplementation on Glycemic and Cardiovascular Risk Factors in Asian Indians in North India With Type 2 Diabetes Mellitus: A 24-week Prospective Cohort Study

Diabetes Foundation, India1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Change in LDL-c

研究概览

简要总结

This prospective cohort study of an almond-enriched diet (within the overall context of Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients in the age range of 25-65 years
  • on stable doses of metformin from past 3 months
  • having HbA1C less than 9%
  • LDL-c ≥100 mg/dl were recruited

排除标准

  • Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years
  • having high uric acid levels (≥ 8 mg/dl),
  • with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure,
  • appreciable weight loss (more than 10%) during past 6 months
  • Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters

结局指标

主要结局

Change in LDL-c

时间窗: baseline, after six months

次要结局

  • HbA1C(baseline, after six months of intervention)

研究者

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

Dr Anoop Misra

Director

Diabetes Foundation, India

研究点 (1)

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