Status:
COMPLETED
Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
Investigators propose a randomized controlled trial of combination phentermine topiramate ER versus placebo given orally for 10-15 days. At visit 1 subjects had a brief interview, body measurements, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01834404
Start Date
April 1 2013
End Date
March 1 2014
Last Update
February 23 2015
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905