Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
NCT ID: NCT00243984
Last Updated: 2007-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
PHASE3
90 participants
INTERVENTIONAL
2005-03-31
2007-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Metabolic syndrome is a constellation of findings which includes dyslipidemia, abdominal obesity, hyperglycemia, and hypertension. Insulin resistance is believed to be the cause whereby obesity increases resistance to insulin. Weight loss in type 2 diabetics is known to reduce insulin resistance and allow for greater glycemic control. Weight loss in pre-diabetics can often forstall the development of diabetes. Additionally, aggressive blood pressure control in diabetics reduces the risk of coronary artery disease. Weight loss reduces blood pressure and is used as first line treatment for hypertension.
Comparison: Patients who meet the criteria for metabolic syndrome and prescribed topiramate will be compared with those patients who meet the same criteria and are prescribed placebo.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
topiramate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI \>/=30kg/m2
* and 3 of the 5 following criteria:
1. Triglycerides \>/=150mg/dl
2. HDL cholesterol \</=40mg/dl (men) or \</=50mg/dl (women)
3. Blood pressure \> 130/85
4. Waist circumference \>/=40inches (men) or \>/=35inches (women)
5. Fasting blood glucose \>/=110mg/dl or diagnosis of type 2 diabetes mellitus
* Able to give informed consent
* Diabetes Mellitus must be well controlled for the past 3 months and HbA1c \</=9.0
* Hypertension must be well controlled for the past 3 months and BP \<140/90
* Willing and able to take oral medication
* Female subjects must be post menopausal for 1 year, surgically sterile, or practicing an effective method of birth control; and have a negative monthly pregnancy test at screening and throughout the study.
Exclusion Criteria
* Renal insufficiency
* Taking medication with known serious interactions with topiramate
* History of psychosis, epilepsy or any other disease in which taking topiramate may interfere with treatment of that disease
* Positive urine drug screen
* Previous treatment with topiramate and subsequent adverse event; or concurrent treatment with topiramate
* History of nephrolithiasis
* Pregnancy or lactating
* Subjects who are members of the same household
* Currently on an exercise or diet plan
* Bariatric surgery within the past 5 years
* Clinically significant medical conditions including (but not limited to) symptomatic coronary artery disease or peripheral vascular disease, or taking nitrates; malignancy or history of malignancy within the past 5 years (except basal cell carcinoma); Impaired renal function as defined by an estimated creatinine clearance \</=60ml/min; Gastrointestinal system diseases including active liver disease; ALT or AST\>2 times the upper limit of normal; Pulmonary disorders; Endocrine disorders except for well controlled diabetes mellitus and hypothyroidism; Any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of topiramate.
* Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings, or contraindications sections of the topiramate package insert
* Family members of employees or investigators and employees of the investigator or study center may participate but may not serve any staff role for themselves.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cleveland Clinic Akron General
OTHER
Forum Health
INDUSTRY
Aultman Health Foundation
OTHER
St. Elizabeth Health Center
UNKNOWN
Mercy Medical Center
OTHER
Northeastern Ohio Universities College of Medicine
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frederick Whittier, MD
Role: PRINCIPAL_INVESTIGATOR
Northeastern Ohio Universities College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akron General Medical Center
Akron, Ohio, United States
Mercy Medical Center
Canton, Ohio, United States
Aultman Hospital
Canton, Ohio, United States
Forum Health/Northside Medical Center
Youngstown, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05005
Identifier Type: -
Identifier Source: org_study_id