A Study to Evaluate Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-011697
NCT ID: NCT04408586
Sponsor Protocol Number: 19-011697
About this study
The purpose of this study is to evaluate the effect of phentermine-topiramate ER (anti-obesity pharmacotherapy) vs. placebo among patients with obesity using a wearable activity tracker as part of standard lifestyle intervention.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults with obesity (BMI > 30Kg/m^2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
- Age: 18-75 years old.
- Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
- Women of childbearing potential must agree to use a method of effective contraception during study participation.
- Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures.
Exclusion Criteria:
- History of Abdominal bariatric surgery.
- Weight is greater than 450 lbs. (204 kg).
- Recent use (within the last three months) of any antiobesity medication.
- Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months).
- Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score > 11 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.
- Hypersensitivity or contraindication to the study medication.
- Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
- Principal Investigator discretion.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available