Clinical trial NCT04453306: Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome
Official title: Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome: a Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Polycystic Ovary Syndrome
Hyperandrogenism
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind Placebo-controlled Clinical Trial
Primary purpose: TREATMENT

Brief summary: Treatment of obesity related to Polycystic Ovary Syndrome with topiramate or placebo to assess improvement of clinical and laboratory parameters after 6 months of follow-up

Detailed description: Randomized double blind placebo-controlled clinical trial. Polycystic ovary syndrome (PCOS) is a frequent endocrinopathy, affecting more than 10% of women of reproductive age. It is associated with a higher prevalence of obesity and insulin resistance, with a higher risk for diabetes, dyslipidemia and hypertension. Topiramate is a drug used in the treatment of epilepsy and migraine prophylaxis since the 1990s and several studies show an association with weight loss. This medicine is administered in combination with phentermine in other countries, with variable weight loss. Despite evidence of the benefit of topiramate for weight loss, there is still no record of studies evaluating this drug in patients with PCOS for the treatment of obesity. The objective of this project is to evaluate the results of treatment with topiramate in terms of weight reduction, reduction of serum androgens and changes in body composition, in patients with PCOS and obese, associated with a low-calorie diet, over a period of six months. Eighty patients with PCOS (18 to 40 years old) seen at the HCPA Endocrinology Service outpatient clinic who are overweight with a BMI\> or = 27 kg / m2 associated with at least one comorbidity or obesity (BMI 30-40) will be included. Patients will be randomized to 2 groups: Topiramate and Placebo and the 2 groups will receive a low-calorie diet.

Anthropometric, clinical, hormonal, nutritional and body composition assessment will be performed before, during and after treatments. It is expected to determine whether the addition of topiramate to dietary treatment can improve metabolic, hormonal and weight loss outcomes in women with PCOS.

Research Objective: General objective: To evaluate the results of treatment with topiramate in patients with PCOS and obese, associated with a low-calorie diet, in six months of treatment.

Specific objectives: To evaluate the response to the proposed treatment in terms of weight reduction and body mass index (BMI), reduction of serum androgens, changes in body composition, in addition to assessing minor psychiatric disorders possibly associated through the Self-Reporting screening questionnaire. Questionnaire (SRQ-20).

Assessment of Risks and Benefits: The risks of the project are mainly related to the use of the drug topiramate. This drug has an extensive list of adverse effects, in addition to the side effect on appetite and weight, the most common are paresthesias, drowsiness, lethargy, attention disorder, mood disorders, depression, taste changes and psychomotor disorders. However, studies show that the majority of adverse reactions were mild to moderate in severity. Other risks inherent to the study are the absence of previous studies in the target population and discomfort in relation to the number of visits, additional tests and blood samples for an extended period of 6 months. The benefits of the study are related to the acquisition of knowledge and the likely positive results may benefit future patients.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 40 years
* diagnostic criteria for PCOS
* overweight with a BMI ≥ 27 kg / m² associated with at least one comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia) or obesity with a BMI between 30 and 45 kg / m² with or without comorbidities

Exclusion Criteria:

* severe systemic arterial hypertension (≥180 / 100 mmHg)
* pregnant or lactating women
* diabetics using sulfonylurea or insulin
* any known allergy or intolerance to topiramate medication

Primary outcomes:
measure: Change of Body Mass index (BMi) at 6 months
timeFrame: 6 months
measure: change in the modified Ferriman-Gallwey Hirsutism Score (mFG) at 6 months
timeFrame: 6 months
measure: Change of testosterone at 6 months
timeFrame: 6 months
measure: Change of glucose at 6 months
timeFrame: 6 months
measure: Change of triglyceride at 6 months
timeFrame: 6 months
measure: Change of High-density lipoprotein (HDL) at 6 months
timeFrame: 6 months
measure: Change of total cholesterol at 6 months
timeFrame: 6 months
measure: Change of Low-density lipoprotein (LDL) at 6 months
timeFrame: 6 months
measure: Change of homeostatic model assessment (HOMA-IR) at 6 months
timeFrame: 6 months
measure: change in systolic blood pressure at 6 months
timeFrame: 6 months
measure: change in diastolic blood pressure at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: change of body composition at 6 months
timeFrame: 6 months
measure: Change in anxiety score at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Poli Mara Spritzer
role: PRINCIPAL_INVESTIGATOR
References: