Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker

Obesity Clinical Trial

Official title:

Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408586
• Other study ID #: 19-011697
• Status: Completed
• Phase: Phase 4
• Start date: June 3, 2020
• Est. completion date: October 11, 2022

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are assessing the effects of weight loss medication vs a placebo among participants provided with a wearable activity tracker, digital wellness devices and lifestyle recommendations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 11, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.

• Age: 18-75 years.

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Phentermine-Topiramate Extended Release
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
• Placebo
Placebo looks exactly like the study drug, but it contains no active ingredient

Other:
• Online support system
VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Change	Change in weight calculated in kilograms.	baseline, 3 months
Secondary	Body Weight Change	Change in weight calculated in kilograms.	baseline, 12 months
Secondary	Change in Step Count	The change in the number of steps per day	baseline,12 months
Secondary	Change in Calories	The change in calories burned per day	baseline, 12 months
Secondary	Exercise Sessions	The number of exercise sessions per week	12 months
Secondary	Tracker Usage	The amount of time in minutes the tracker was used per week	12 months
Secondary	Change in SF-12 Physical Score (Health-related Quality Quality of Life)	Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome	baseline, 12 months
Secondary	Change in SF-12 Mental Score (Health-related Quality Quality of Life)	Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.	baseline, 12 months

External Links

•   Mayo Clinic Clinical Trials