Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome

NCT04453306 | Unknown Phase 4

• 1 other identifier: 140228
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Polycystic Ovary Syndrome; Hyperandrogenism

Outcome Measures

Primary Outcomes (11)

• 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

  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.

  6 months

• Change of testosterone at 6 months

  Change of testosterone (ng/mL) at 6 months from the baseline

  6 months

• Change of glucose at 6 months

  Change of glucose(mg/dL) at 6 months from the baseline

  6 months

• Change of triglyceride at 6 months

  Change of triglyceride (mg/dL) at 6 months from the baseline

  6 months

• Change of High-density lipoprotein (HDL) at 6 months

  Change of HDL cholesterol (mg/dL) at 6 months from the baseline

  6 months

• Change of total cholesterol at 6 months

  Change of total cholesterol (mg/dL) at 6 months from the baseline

  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

  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.

  6 months

• change in systolic blood pressure at 6 months

  change in systolic blood pressure (mmHg) at 6 months from baseline.

  6 months

• change in diastolic blood pressure at 6 months

  change in diastolic blood pressure (mmHg) at 6 months from baseline.

  6 months

Secondary Outcomes (2)

• change of body composition at 6 months

  6 months

• Change in anxiety score at 6 months

  6 months

Study Arms (2)

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.

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.

Drug: Topiramate

Interventions

Topiramate DRUG

topiramate 25mg is coated in tablets in an independent laboratory

intervention

Placebo DRUG

innocuous substance is coated in tablets in an independent laboratory

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity; Polycystic Ovary Syndrome; Hyperandrogenism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Poli Mara Spritzer

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Marchesan

CONTACT

+55 51 993873838; lucas.iuk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants, caregivers, researchers and outcome assessors are blinded to the medications participants are receiving. Participants receive pills with identical size, color and taste between the placebo and the active drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind Placebo-controlled Clinical Trial

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 1, 2020
• Study Start: May 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

BR (1)