Clinical trial NCT00243984 (phase 3, status: suspended)
Conditions: metabolic syndrome x, diabetes mellitus, type 2
ICD codes: E88.81, G93.41, E88.9, P19.9, E88.89, O21.1, P19.2, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: topiramate
SMILES: [H][C@@]12CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@@]3([H])[C@]1([H])OC(C)(C)O2
Reason stopped: 
    study was discontinued because of high drop out rate.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Metabolic Syndrome

          -  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:

          -  Any person unable to take topiramate

          -  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.