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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Oral Cinnamon Extract
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Polycystic ovary syndrome Exclusion Criteria: Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cinnamon Extract<br>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. | Drug: Oral Cinnamon Extract<br>* 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.<br>* Other names: Cinnamon Extract;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo pills in likeness of the cinnamon extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose |  | Duration of study | 
| Fasting insulin |  | Duration of study | 
| HOMA-IR |  | Up to 8 weeks after treatment | 
| QUICKI |  | Up to 8 weeks after treatment | 
| Insulin sensitivity index (Matsuda) |  | Up to 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total testosterone |  | Up to 8 weeks after treatment | 
| Sex hormbone binding globulin |  | Up to 8 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, insulin resistance, cinnamon