Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients
Condition: Obesity
MeSH terms: Obesity
Intervention: Phentermine-Topiramate ER; Placebo
Intervention description: The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.; Placebo pills matched the study drug in appearance for the 2 dose levels.
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; BMI; Incretin; Satiety; Phentermine; Topiramate

Summary:

      Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric
      emptying, gastric accommodation, satiety, and satiation in obese participants.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Obese subjects with BMI> 30 Kg/m^2. Otherwise healthy individuals who are not
             currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal,
             hematological, neurological, endocrine (other than hyperglycemia not requiring medical
             therapy) and unstable psychiatric disease.

          -  Women of childbearing potential will have negative pregnancy test before initiation of
             medication.

        EXCLUSION CRITERIA:

          -  Weight >300 lbs, which is the limit of safety for the SPECT scanner

          -  Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or
             orlistat (Xenical®)

          -  Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)

          -  Concentration of fasting glucose greater than 240 mg/dl

          -  Concentration of triglycerides greater than 400 mg/dl

          -  Type 1 Diabetes

          -  Use of anti-diabetic drugs other than metformin,

          -  History of nephrolithiasis,

          -  Recurrent major depression, presence or history of suicidal behavior or ideation with
             intent to act, and current substantial depressive symptoms (Patient Health
             Questionnaire-9, 21 total score ≥10).

          -  Concomitant use of Monoamine Oxidase Inhibitors (MAOI) (i.e., phenelzine, selegiline),
             serotonergic agents, and other centrally acting appetite suppressants

          -  Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and
             Depression Scale [HADS] self-administered alcoholism screening test (SAAST, substance
             abuse) and the questionnaire on eating and weight patterns (binge eating disorders and
             bulimia). If such a dysfunction is identified by a Hospital Anxiety and Depression
             Scale (HADS) score ≥11 in any of the subscales or difficulties with substance or
             eating disorders, the participant will be excluded and given a referral letter to
             his/her primary care doctor for further appraisal and follow-up.

          -  End stage renal disease or liver cirrhosis

          -  Intake of medication that could interfere with the interpretation of the study or
             cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control
             pill, estrogen replacement therapy, and thyroxine replacement are permissible.