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Study on Acupuncture and Metformin for Improving Insulin Sensitivity in Women with Polycystic Ovary Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Polycystic Ovary Syndrome (PCOS), a condition that affects women's hormone levels, leading to symptoms like irregular periods, acne, and excess hair growth. The study will explore the effects of two treatments: acupuncture and Metformin, a medication commonly used to improve insulin sensitivity, which is how well the body responds to insulin, a hormone that helps control blood sugar levels.

The purpose of the study is to determine how effective these treatments are in improving insulin sensitivity in women with PCOS. Participants will be divided into three groups: one group will receive acupuncture along with lifestyle management, another group will take Metformin along with lifestyle management, and the third group will only follow lifestyle management. Lifestyle management typically includes changes in diet and exercise habits. The study will last for about four months.

Throughout the study, participants will undergo various tests to measure changes in their insulin sensitivity and other related health markers. These tests will help researchers understand how each treatment affects the body and whether it can help manage symptoms of PCOS. The study aims to provide valuable insights into the potential benefits of acupuncture and Metformin for women with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of three groups. Each group will follow a different treatment plan for improving insulin sensitivity in women with polycystic ovary syndrome (PCOS).
Step 2
Treatment group assignment
If you are assigned to the first group, you will receive acupuncture sessions along with lifestyle management advice.
If you are assigned to the second group, you will take Metformin Actavis 500 mg film-coated tablets orally. The dosage and frequency will be determined by the study team, and you will also receive lifestyle management advice.
If you are assigned to the third group, you will receive lifestyle management advice only.
Step 3
Treatment duration
The treatment will last for a period of 4 months. During this time, you will follow the assigned treatment plan based on your group.
Step 4
Monitoring and assessments
Throughout the study, your insulin sensitivity will be monitored. This will involve tests such as the oral glucose tolerance test (OGTT) to measure your body's response to glucose.
Additional assessments will include measuring changes in insulin sensitivity using the HOMA-IR method, and analyzing glucose regulation through Hba1c levels.
Step 5
End of study evaluations
At the end of the 4-month period, further evaluations will be conducted to assess changes in metabolic measures, including fasting insulin, c-peptide, glucose, and other related factors.
The study will also evaluate changes in gene expression and other biological markers related to insulin sensitivity.

Who can join the trial?

7 criteria

Women with Polycystic Ovary Syndrome (PCOS).
Age between 18 to 40 years.
Body Mass Index (BMI) between 25 and 45. For Chinese women, BMI should be between 23 and 37.5. BMI is a measure of body fat based on height and weight.
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PCOS diagnosis according to the Rotterdam criteria 2003, which includes at least two of the following:
- Clinical signs of hyperandrogenism (such as excessive hair growth or acne). Hyperandrogenism means having high levels of male hormones.
- Oligomenorrhea or amenorrhea. Oligomenorrhea means having menstrual cycles longer than 35 days or fewer than 8 periods in a year. Amenorrhea means having fewer than 3 periods in a year.
- Polycystic ovaries as seen on an ultrasound. This means having 12 or more small follicles in the ovaries or an increased ovarian volume.
- Willing to sign the consent form to participate in the study.

Who cannot join the trial?

8 criteria

Participants must not have any other serious medical conditions that could interfere with the study.
Participants should not be pregnant or planning to become pregnant during the study.
Participants must not be currently taking medications that affect insulin sensitivity, except for metformin.
Participants should not have a history of allergic reactions to metformin or any components of the study treatments.
Participants must not have participated in another clinical trial within the last 30 days.
Participants should not have a history of drug or alcohol abuse.
Participants must not have any mental health conditions that could affect their ability to follow the study procedures.
Participants should not have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

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Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Acupuncture
is a therapy that involves inserting very thin needles through your skin at specific points on your body. It is a key component of traditional Chinese medicine and is often used to treat pain. In this trial, acupuncture is being used alongside lifestyle management to see if it can help improve insulin sensitivity in women with Polycystic Ovary Syndrome (PCOS). The idea is that acupuncture might help the body respond better to insulin, which is important for managing blood sugar levels.
Metformin
is a medication commonly used to treat type 2 diabetes. It helps control blood sugar levels by improving the way your body handles insulin. In this trial, metformin is being used with lifestyle management to see if it can help improve insulin sensitivity in women with PCOS. The goal is to see if metformin can help the body use insulin more effectively, which is important for keeping blood sugar levels stable.

Metformin Hydrochloride

What is already known about the treatment

Metformin – Metformin is a medication taken orally, usually in the form of a tablet, and is commonly used to help manage blood sugar levels in people with type 2 diabetes. In medical literature, it is well-established as a treatment for improving insulin sensitivity, which is particularly beneficial for women with polycystic ovary syndrome (PCOS). Metformin works by reducing the amount of sugar produced by the liver and increasing the sensitivity of muscle cells to insulin, helping the body use insulin more effectively. It is classified as a biguanide, a type of drug that helps control blood sugar levels.

Investigated diseases

Polycystic ovary syndrome – Polycystic ovary syndrome is a hormonal disorder common among women of reproductive age. It is characterized by irregular menstrual periods, excess androgen levels, and polycystic ovaries. The condition often leads to the development of numerous small collections of fluid (follicles) in the ovaries and may cause the ovaries to fail to regularly release eggs. Over time, this can result in difficulties with fertility. The syndrome is also associated with insulin resistance, which can lead to increased insulin levels in the body. This insulin resistance can contribute to weight gain and difficulty losing weight.