CLINICAL TRIAL

Treatment for Obesity

Recruiting · 18+ · All Sexes · Rochester, MN

This study is evaluating whether weight loss medication may help participants lose weight.

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About the trial for Obesity

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
Placebo
DRUG
+
Online support system
OTHER
Control Group 2
Phentermine-Topiramate Extended Release
DRUG
+
Online support system
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Women who could potentially get pregnant must agree to use a method of birth control while participating in the study. show original
and restrictions The person must be able to understand what they are consenting to, be willing to comply with the study procedures, and be able to give written consent. show original
-Individual must own an Apple iPhone 6s or later that runs on iOS 13 or later in order to qualify for the study show original
Adults who are obese will be healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases. show original
Age: 18-75 years.
Both men and women are eligible to participate in the study, but women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Obesity. Measurement will happen over the course of 3 months.

Primary Endpoint
3 MONTHS
Total body weight loss (%) at 3 months
3 MONTHS
Secondary Endpoints
12 MONTHS
Improvement in obesity-related comorbidities (yes/no)
12 MONTHS

Who is running the study

Principal Investigator
A. J. A. M. P.
Andres J. Acosta M.D., Ph.D., Principal Investigator
Mayo Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can obesity be cured?

We found a strong inverse association between obesity and mortality that is consistent with the results of several cohort studies and observational studies in other health care systems, with potential relevance for the treatment of obesity.

Anonymous Patient Answer

What are common treatments for obesity?

In a significant number of patient’s obesity is not addressed at the time of the initial diagnosis which leads often to weight gain, in most cases to a substantial degree. Pharmacological therapy for hypertension and overweight is sometimes used, but to a limited extent, and is less successful. Obesity itself is not addressed directly, except for bariatric surgery.

Anonymous Patient Answer

How many people get obesity a year in the United States?

Obesity rates have increased among children, young adults, and the elderly. Obese individuals with body mass index (BMI) values above the current national definition of obesity in children and young adults are most likely to experience obesity-related disease. Therefore, the BMI used in epidemiological surveys should be adjusted for age, sex, puberty status, and geographic region.

Anonymous Patient Answer

What is obesity?

Obesity is a condition where a person has excess weight. It can be estimated by BMI. It is associated with obesity-related diseases like diabetes, cardiovascular disease, some types of cancer, and osteoarthritis.

Anonymous Patient Answer

What are the signs of obesity?

Signs of obesity include lack of physical activity, low physical ability, weight gain, and loss of muscularity. The onset is typically at age 20, and is usually associated with weight problems. These people may be overweight, obese, or both.

Anonymous Patient Answer

What causes obesity?

There is a clear relationship among high rates of obesity, lack of physical activity and unhealthy eating habits, in which people fail to consume a full range of available foodstuffs because of lack of knowledge and skills. There is no one clear cause of obesity. The most salient factors, which act in an additive manner, are lack of physical activity and unhealthy lifestyle factors in which people have adopted eating high calorie junk food as a way of avoiding hunger.

Anonymous Patient Answer

What are the common side effects of treatment?

Many of these side effects are related to weight loss: fatigue, loss of appetite, constipation, stomach upset, headaches, feeling faint or vertigo, dizziness, and dry lips. Other side effects are common and often go away with weight loss and may be related to the weight management program: abdominal pain, loss of blood, numbness or tingling of limbs, and swelling. A small number of people experience a few other side effects but can't necessarily attribute these to the weight management program and many have experienced side effects related to weight loss before or since being in a program. Some of the side effects of obesity treatment appear to be due to unhealthy behaviors, genetics, and/or lack of adherence to medication.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Although several of the studies reported no significant differences in adherence to treatments, patients receiving a combination of medications reported being better-treated than those on monotherapy. Thus patients should be advised that the addition of a medication to diet/drug regimen should increase the chance of weight loss in those with obesity.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Weight loss treatments using caloric restriction, sustained-release oral medications and exercise, and non-caloric medications, when compared with placebo, have been proven to be effective in treating obesity over a 6-month period in a randomized, double-blind, placebo-controlled study. Results from multiple randomized, controlled trials have shown that a weight fluctuation of at least 2 lb/week during weight loss therapy is associated with better long-term treatment outcomes than for those treated with a placebo. Because of the potential for both adverse events and lack of information about effectiveness on treating obesity, it is recommended that the use of some weight loss treatments be monitored carefully.

Anonymous Patient Answer

Have there been any new discoveries for treating obesity?

Although more research is needed to confirm or refute the results of this study, the treatment options might be improved using a variety of techniques and medications. The treatments that may be of the most help are those for reducing body fat and managing obesity in an overall healthy manner. Physicians and patients need to keep in mind that there is not one ideal treatment for obesity; each patient must individualize treatment based on factors such as the cause and effects of the disease. A multidisciplinary approach tailored to the patient is necessary, so that the whole person is treated, instead of only focusing on weight loss at a certain time. Physicians may be encouraged to use weight loss in their practice if the problem is not caused by a simple disorder such as obesity.

Anonymous Patient Answer

Does treatment improve quality of life for those with obesity?

In this population, there was a significant improvement with weight maintenance in one area of the QALY. The other areas improved but did not reach statistical significance.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

There have been several small pilot clinical trials involving treatment, but none have shown any conclusive efficacy. Further, none have lasted more than one year. In addition, most studies were uncontrolled, with one study of moderate sizes ( n = 382) being the only controlled study reported, but found no evidence of benefit or detrimental effects. A recently published uncontrolled trial of an intensive inpatient treatment programme ( n=75), however, did indicate some improvement in some parameters of obesity (body mass index and waist circumference) and in metabolic and endocrine disorders (glucose levels, insulin, leptin, and triglycerides). However, the data remain preliminary as of August 2008.

Anonymous Patient Answer
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