ObesityPhase 4NCT04453306
Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome
A Phase 4 study testing Topiramate in people with Obesity and Polycystic Ovary Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity, Polycystic Ovary Syndrome, Hyperandrogenism
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- severe systemic arterial hypertension (≥180 / 100 mmHg)
- pregnant or lactating women
- diabetics using sulfonylurea or insulin
- any known allergy or intolerance to topiramate medication
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
Lucas B Marchesan, +55 51 993873838, lucas.iuk@gmail.com
About this study
Official title: Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome: a Double-blind Placebo-controlled Clinical Trial
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
Read the 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.
- Conditions
- Obesity, Polycystic Ovary Syndrome, Hyperandrogenism
- Being tested
- Topiramate, Placebo
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
topiramate 25mg is coated in tablets in an independent laboratory
PlaceboDrug
innocuous substance is coated in tablets in an independent laboratory
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Patients with the same characteristics as the intervention group. Bottles containing 30 white and green tablets are provided to the participants. The number of bottles is anticipated according to the day of the next appointment. Patients should take 2 tablets bedtime with a full glass of water.
Bottles are labeled as TPMT100 or TPMT200. The dosage of each tablet is 25 mg, totaling 50 mg / day. The dosage is doubled at 3 months if the patient does not lose at least 3% of the initial weight. Receives: Drug: Placebo |
| intervention | Experimental | Patients with the same characteristics as the placebo group. Bottles containing 30 white and green tablets are provided to the participants. The number of bottles is anticipated according to the day of the next appointment. Patients should take 2 tablets bedtime with a full glass of water.
Bottles are labeled as TPMT100 or TPMT200. The dosage of each tablet is 25 mg, totaling 50 mg / day. The dosage is doubled at 3 months if the patient does not lose at least 3% of the initial weight. Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Body Mass index (BMi) at 6 months
change of Body Mass index (BMi) in kg/m² from the baseline; weight and height will be combined to report BMI
Measured: 6 months
change in the modified Ferriman-Gallwey Hirsutism Score (mFG) at 6 months
In the modified method, hair growth is rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations (Upper lip, Chin, Chest, Upper back, Lower back, Upper abdomen, Lower abdomen, Upper arms, Thighs). A patient's score may therefore range from a minimum score of 0 to a maximum score of 36. A score of 6 or higher will be adopted as indicative of androgen excess.
Measured: 6 months
Change of testosterone at 6 months
Change of testosterone (ng/mL) at 6 months from the baseline
Measured: 6 months
Change of glucose at 6 months
Change of glucose(mg/dL) at 6 months from the baseline
Measured: 6 months
Change of triglyceride at 6 months
Change of triglyceride (mg/dL) at 6 months from the baseline
Measured: 6 months
Change of High-density lipoprotein (HDL) at 6 months
Change of HDL cholesterol (mg/dL) at 6 months from the baseline
Measured: 6 months
Change of total cholesterol at 6 months
Change of total cholesterol (mg/dL) at 6 months from the baseline
Measured: 6 months
Change of Low-density lipoprotein (LDL) at 6 months
Change of LDL cholesterol (mg/dL) at 6 months from the baseline. LDL cholesterol will be calculated with the Friedewald formula, an estimation of LDL-c level that uses the following levels of total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-c): LDL-c (mg/dL) = TC (mg/dL) - HDL-c (mg/dL) - TG (mg/dL)/5
Measured: 6 months
Change of homeostatic model assessment (HOMA-IR) at 6 months
Change of HOMA-IR at 6 months from the baseline. HOMA-IR will be calculated according to the formula: fasting insulin (µU/L) x fasting glucose (nmol/L)/22.5.
Measured: 6 months
change in systolic blood pressure at 6 months
change in systolic blood pressure (mmHg) at 6 months from baseline.
Measured: 6 months
change in diastolic blood pressure at 6 months
change in diastolic blood pressure (mmHg) at 6 months from baseline.
Measured: 6 months
Secondary outcomes (2)
change of body composition at 6 months
Change in body composition evaluated through Dual-energy X-ray absorptiometry (DXA) from the baseline
Measured: 6 months
Change in anxiety score at 6 months
Change in anxiety score, assessed through the self-report questionnaire-20 (SRQ 20), consisting of 20 questions with a yes / no answer, assigning 1 point to the "yes" answer. A cut-off point of 8 or more indicates an anxiety disorder, with a minimum of zero and a maximum of 20 points.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startMay 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind Placebo-controlled Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poli Mara Spritzer, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453306
- Sponsor's protocol ID
- 140228
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome: a Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04453306
- Acronym / sponsor ID
- 140228
- Conditions
- Obesity, Polycystic Ovary Syndrome, Hyperandrogenism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind Placebo-controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboPatients with the same characteristics as the intervention group. Bottles containing 30 white and green tablets are provided to the participants. The number of bottles is anticipated according to the day of the next appointment. Patients should take 2 tablets bedtime with a full glass of water. Bottles are labeled as TPMT100 or TPMT200. The dosage of each tablet is 25 mg, totaling 50 mg / day. The dosage is doubled at 3 months if the patient does not lose at least 3% of the initial weight. |
| intervention | Experimental | Drug: TopiramatePatients with the same characteristics as the placebo group. Bottles containing 30 white and green tablets are provided to the participants. The number of bottles is anticipated according to the day of the next appointment. Patients should take 2 tablets bedtime with a full glass of water. Bottles are labeled as TPMT100 or TPMT200. The dosage of each tablet is 25 mg, totaling 50 mg / day. The dosage is doubled at 3 months if the patient does not lose at least 3% of the initial weight. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- severe systemic arterial hypertension (≥180 / 100 mmHg)
- pregnant or lactating women
- diabetics using sulfonylurea or insulin
- any known allergy or intolerance to topiramate medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramatetopiramate 25mg is coated in tablets in an independent laboratory | Drug | intervention |
| Placeboinnocuous substance is coated in tablets in an independent laboratory | Drug | placebo |
Primary outcome
Change of Body Mass index (BMi) at 6 months
Time frame: 6 months
change of Body Mass index (BMi) in kg/m² from the baseline; weight and height will be combined to report BMI
change in the modified Ferriman-Gallwey Hirsutism Score (mFG) at 6 months
Time frame: 6 months
In the modified method, hair growth is rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations (Upper lip, Chin, Chest, Upper back, Lower back, Upper abdomen, Lower abdomen, Upper arms, Thighs). A patient's score may therefore range from a minimum score of 0 to a maximum score of 36. A score of 6 or higher will be adopted as indicative of androgen excess.
Change of testosterone at 6 months
Time frame: 6 months
Change of testosterone (ng/mL) at 6 months from the baseline
Change of glucose at 6 months
Time frame: 6 months
Change of glucose(mg/dL) at 6 months from the baseline
Change of triglyceride at 6 months
Time frame: 6 months
Change of triglyceride (mg/dL) at 6 months from the baseline
Change of High-density lipoprotein (HDL) at 6 months
Time frame: 6 months
Change of HDL cholesterol (mg/dL) at 6 months from the baseline
Change of total cholesterol at 6 months
Time frame: 6 months
Change of total cholesterol (mg/dL) at 6 months from the baseline
Change of Low-density lipoprotein (LDL) at 6 months
Time frame: 6 months
Change of LDL cholesterol (mg/dL) at 6 months from the baseline. LDL cholesterol will be calculated with the Friedewald formula, an estimation of LDL-c level that uses the following levels of total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-c): LDL-c (mg/dL) = TC (mg/dL) - HDL-c (mg/dL) - TG (mg/dL)/5
Change of homeostatic model assessment (HOMA-IR) at 6 months
Time frame: 6 months
Change of HOMA-IR at 6 months from the baseline. HOMA-IR will be calculated according to the formula: fasting insulin (µU/L) x fasting glucose (nmol/L)/22.5.
change in systolic blood pressure at 6 months
Time frame: 6 months
change in systolic blood pressure (mmHg) at 6 months from baseline.
change in diastolic blood pressure at 6 months
Time frame: 6 months
change in diastolic blood pressure (mmHg) at 6 months from baseline.
2 secondary outcomes
change of body composition at 6 months
Time frame: 6 months
Change in anxiety score at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poli Mara Spritzer principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Obesity and Polycystic Ovary Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas Marchesan (+55 51 993873838, lucas.iuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Body Mass index (BMi) at 6 months (time frame: 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.