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Phentermine-Topiramate + Lifestyle Intervention for Obesity
N/A
Recruiting
Led By Lisa L Morselli, MD PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial looks for biomarkers that could help predict how someone will respond to weight loss, in terms of their metabolism.
Who is the study for?
This trial is for individuals with a BMI of 30 or higher, from any ethnic background. It's not suitable for those with heart disease, active cancer, post-transplant patients, weight over 400 lbs., HIV/AIDS, pregnant or breastfeeding women, smokers, and people with liver or kidney disease, diabetes (type 1 or type 2), or hypertension.Check my eligibility
What is being tested?
The study tests if phentermine-topiramate combined with lifestyle changes affects metabolic adaptation after weight loss differently than just lifestyle changes and meal replacements. Researchers are looking at how the body adjusts its energy use during and after dieting.See study design
What are the potential side effects?
Phentermine-topiramate can cause dry mouth, constipation, numbness in limbs; it may also affect mood and sleep. Lifestyle interventions might lead to temporary fatigue or hunger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in measured and predicted resting metabolic rate during and after weight loss
Secondary outcome measures
change in 24h urine catecholamines during and after weight loss
change in circulating AgRP during and after weight loss
change in circulating GLP-1 during and after weight loss
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: lifestyle intervention plus phentermine-topiramateExperimental Treatment1 Intervention
Participants will be enrolled in a weight loss program based on lifestyle changes and the use of phentermine-topiramate to aid with weight loss
Group II: lifestyle interventionExperimental Treatment1 Intervention
Participants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching.
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,523 Total Patients Enrolled
3 Trials studying Weight Loss
280 Patients Enrolled for Weight Loss
Lisa L Morselli, MD PhDPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I have liver disease.I have heart disease.My cancer is currently active.You are currently using illegal drugs for non-medical purposes.You are currently breastfeeding a baby.You are pregnant.I have had a solid organ or bone marrow transplant.You are currently smoking cigarettes.I am living with HIV/AIDS.I have kidney disease.I have high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: lifestyle intervention plus phentermine-topiramate
- Group 2: lifestyle intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Weight Loss Patient Testimony for trial: Trial Name: NCT05139420 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any criteria for me to be eligible to join this research?
"This trial is recruiting 60 individuals aged 18-50 who have experienced weight loss and a BMI greater than or equal to 30. It does not matter of the participants' ethnicity."
Answered by AI
Are any participants over the age of 30 being included in this research endeavor?
"According to the criteria, this medical trial is only open for patients between 18 and 50 years old. In contrast, there are 236 studies available for those below the age of consent and 714 trials designed for seniors over 65."
Answered by AI
Are there any vacancies left for participants in this clinical study?
"Current information found on clinicaltrials.gov reveals that this medical trial is actively seeking participants. This project, which was established on September 10th 2022, has been updated as recently as August 24th of the same year."
Answered by AI
Are there any limits to the number of participants in this trial?
"Confirmed, the clinicaltrials.gov website shows that this experiment is open to new participants and has been so since September 10th 2022. The latest update was made on August 24th of the same year and 60 people are needed at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Iowa
Other
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Medical College of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Obesity: BMI about 32. Little fluctuation of weight gain or less: seem to be at a set point.
PatientReceived no prior treatments
I'm tired of struggling with weight, dieting, and medication causing weight gain. I want to be able to run or go up stairs without strain.
PatientReceived 1 prior treatment
I have had a rough couple years of being unable to work out, and spend a long amount of time in my car driving for work. Since moving to Wisconsin from Oklahoma, I have gained 45 pounds and have battled to to lose it.
PatientReceived no prior treatments
I have chronic pain, migraines, fibromyalgia, osteoporosis, and a number of other health conditions. Being obese doesn’t help these conditions get better or my disability. A long time ago I lost a lot of weight with the help of a medication that is no longer on the market and I can’t afford the medication but would love to be in a study to help myself and other people to lose weight. Thank you for your consideration!! Donna.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Medical College of Wisconsin: < 48 hours
Typically responds via
Email
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