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临床试验/NCT00331279
NCT00331279已完成1 期

The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study

Columbia University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
1
试验地点
1
主要终点
Fasting glucose

研究概览

简要总结

The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.

详细描述

Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus.

Although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has been found to have high insulin levels.

Medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of PCOS such as irregular periods.

Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. Another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. The purpose of this study is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be used as a treatment for irregular periods as well.

Half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. A total of three separate visits will be needed to finish the study. At the end of the study, we will then compare the blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
23 Years 至 47 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Polycystic ovary syndrome

排除标准

  • Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

研究组 & 干预措施

Cinnamon Extract

Active Comparator

A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.

干预措施: Oral Cinnamon Extract (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Fasting glucose

时间窗: Duration of study

Fasting insulin

时间窗: Duration of study

HOMA-IR

时间窗: Up to 8 weeks after treatment

QUICKI

时间窗: Up to 8 weeks after treatment

Insulin sensitivity index (Matsuda)

时间窗: Up to 8 weeks after treatment

次要结局

  • Total testosterone(Up to 8 weeks after treatment)
  • Sex hormbone binding globulin(Up to 8 weeks after treatment)

研究者

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

Rogerio A. Lobo

Professor

Columbia University

研究点 (1)

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