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Insulin

Insulin, Globin Zinc

Cinnamon

PCOS patients receiving abstract of cinnamon

Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Cinnamon Extract

Placebo capsules containing ground cereal.

Placebo

Rogerio Lobo, MD

The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study subjects.

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.

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. Our own study also showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more regular periods.

All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar.

Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.

Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)

The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome

Ovulatory cycles will be confirmed by serum progesterone levels.

The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of \>2 is considered healthy for adults with scores \>5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).

Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.

Integrity Nutraceuticals International

Rogerio A. Lobo

Professor of Obstetrics and Gynecology

PCOS patients receiving extract of cinnamon

Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Cinnamon Extract Arm

PCOS patients receiving placebo capsules

Placebo: Placebo capsules containing ground cereal.

Placebo Arm

Purified aqueous abstract of cinnamon in 125mg capsules

Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Placebo capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

High percentage of patients lost to follow up

Roger A. Lobo M.D.

Baseline

Study Period

Purified aqueous abstract of cinnamon in 125mg capsules

Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23

Placebo capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.

Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13

Number of Menses During the Six Month Study Period.

Homeostasis Model of Insulin Resistance - Baseline

Homeostasis Model of Insulin Resistance - 6 months

Quant. Insulin Sensitivity Check Index - Baseline

Quant. Insulin Sensitivity Check Index - 6 months

Change in Insulin Resistance

Glucose Response (Area under curve) - Baseline

Glucose Response (Area under curve) - 6 months

Change in Glucose Response

Overall Study

Diseases and Abnormalities at or Before Birth

Rare Diseases

Hyperandrogenism

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Anti-Infective Agents

Anti-Bacterial Agents

Androgens

Doxycycline

Antibiotics, Antitubercular

Matrix Metalloproteinase Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.

The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control

200mg/day in divided doses of 100mg twice daily

doxycycline

Sugar Pill

Kathleen M Hoeger, MD, MPH

Stephen Hammes, MD

The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).

Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.

Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome

The Use of an MMP Inhibitor, Doxycycline, to Reduce Ovarian Androgen Production and Restore Normal Cycling in Women With Polycystic Ovarian Syndrome

We will determine total serum testosterone levels in all participating subjects at week 24.

We will determine total serum testosterone levels in all participating subjects at week 12.

Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.

The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.

University of Rochester

Professor

Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.

doxycycline: 200mg/day in divided doses of 100mg twice daily

The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control

Sugar Pill: 1 pill twice a day

Age, Categorical

total serum testosterone

free serum testosterone

serum hormone binding globulin (SHBG)

This study was underpowered due to reduced enrollment. Targeted enrollment was 40 and actual enrollment was 10.

Kathleen Hoeger MD MPH

in the sugar pill arm one participant dropped out at week 12

Total Serum Testosterone

This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.

Serum Progesterone Levels in Blood

Free Testosterone in Serum

in the sugar till arm, one participant dropped out at week 12

Serum Hormone Binding Globulin (SHBG)

in the sugar pill arm, one participant withdrew at week 12

In the sugar pill arm, one participant withdrew at week 12.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)	NCT01483118	Polycystic Ovar...	Cinnamon Extrac... Placebo	18 Years - 38 Years	Columbia University
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome	NCT01788215	Polycystic Ovar... Irregular Menst... Androgen Excess	doxycycline Sugar Pill	18 Years - 40 Years	University of Rochester

Spots Global Cancer Trial Database for irregular menstrual cycles