CLINICAL TRIAL

TOGA for Obesity

Waitlist Available · 18 - 65 · All Sexes · Minneapolis, MN

This study is evaluating whether a surgery to reduce stomach size can help people lose weight.

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About the trial for Obesity

Treatment Groups

This trial involves 2 different treatments. TOGA 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 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
TOGA
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Control
DEVICE

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People have been trying to lose weight without surgery for many years, but with little success show original
The subject plans to remain within a 100 mile radius of the study center for the next 5 years. show original
Age 18-60
People who are obese, with a BMI of more than 40 kilograms per meter squared, or obese with a BMI of more than 35 kilograms per meter squared and one or more significant co morbidities, are considered to be morbidly obese. show original
The person has been obese for at least 2.5 years. show original
The person has had stable weight for one year prior to the screening visit. 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
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 TOGA will improve 1 primary outcome and 1 secondary outcome in patients with Obesity. Measurement will happen over the course of 12 months.

Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures
12 MONTHS
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC)
12 MONTHS

Patient Q & A Section

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

What causes obesity?

When children eat appropriately, they gain fewer calories compared with the average intake per day, with each unit of extra calories consumed at a faster rate. This difference is a consequence of how different food groups work in combination. Parents need to keep in mind that overeating of foods high in fat and high in sugars is the cause of obesity and that healthy meals and a nutritious diet will keep their children's obesity level down to a healthy weight. Children whose parents restrict what and what quantity they eat will end up overeating more than their healthy counterparts.

Anonymous Patient Answer

Can obesity be cured?

Based on findings from medical centers, the rate of spontaneous weight loss for overweight individuals is exceedingly low (7%), and, the vast majority of individuals have difficulty losing more than the 5%-7% of fat that remains. Obesity is a chronic disease which is responsive to lifestyle change and which is often not permanently solved by dieting. Lifestyle changes are only as beneficial as the underlying issues which cause an individual’s obesity.

Anonymous Patient Answer

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

around 26 million obese persons (defined by the guidelines of the American Heart Association) and 1 in 17 obese women have this condition. These numbers are rising. More information is needed on its prevalence, to clarify the relationship between obesity and several chronic conditions and death, in order to formulate prevention strategies and intervention programs.

Anonymous Patient Answer

What are common treatments for obesity?

There is a high incidence of obesity in our population with comorbidities, including high cholesterol, diabetes, and hypertension. The treatment is mainly nutritional but exercise and lifestyle modifications are recommended as well.

Anonymous Patient Answer

What is obesity?

Obesity, where BMI > 30, is a chronic disease that negatively affects one's health and life expectancy; it also is marked by excessive adipose tissue and central fat deposition.

Anonymous Patient Answer

What are the signs of obesity?

The signs of obesity include: an increased body mass and abdominal swelling. Other symptoms may include: sleep difficulty, irregular heartbeat, and lack of libido. There are several measures that can be taken to improve obesity, including: regular exercise, eating a healthy diet, limiting alcohol, and reducing sedentary behavior.

Anonymous Patient Answer

Has toga proven to be more effective than a placebo?

Our conclusions can be summarized as follows: The toga may work. However, its effect is not mediated by the placebo effect. We did not find any effects of the placebo on physical activity, as measured using the accelerometers worn by the participants. Therefore, we cannot recommend toga as a placebo for the treatment of obesity.

Anonymous Patient Answer

Have there been any new discoveries for treating obesity?

There is still a long way to go for research on obesity; one thing that has been uncovered is that obesity is more likely the result of a combination of genes, as opposed to just genes. For now, there is not enough research on obesity management to know what the best approach is. Also, there is an absence of any new, specific medication treatments for obesity. However, some recent reviews suggest that there are some medications that might help obese humans. They also point out that although some medications might make obese persons lose weight, they might have an adverse effect that they want to avoid, as well.\n\nThe most effective weight loss approaches are behavioral, nutritional, or surgical.

Anonymous Patient Answer

What is the primary cause of obesity?

The cause of all obesity is the same: there is no one single cause. Obesity can be caused by biological inheritance, psychosocial factors, an environment that is triggering biological obesity, and genetics. If the genetic predisposition is the same, many of us tend to put too much emphasis on what we eat, and when we eat, as the prime cause of obesity, or at least an immense reason. But many others see the primary cause of obesity as not being in the eating nor in the eating, but in the environment from which the food is being brought by a person who is obese. Another cause of obesity that does not have a biological mechanism (yet) is where the fatness is being brought on or exacerbated by drugs or alcohol.

Anonymous Patient Answer

What is the latest research for obesity?

There is an ongoing need to develop quality clinical practice guidelines and evidence-based interventions of proven effectiveness for overweight people. There is an increasing awareness of the importance of considering all aspects of an individual's lifestyle and identifying specific actions to be taken when appropriate. The need to intervene specifically with individuals at risk of developing obesity are identified as a priority. Evidence-based practice guidelines should contain key recommendations for overweight and obese people as well as be based on the principles of evidence-based medicine and cost effectiveness.

Anonymous Patient Answer

What is the average age someone gets obesity?

Rates of overweight and obesity are increasing rapidly in Europe. Results from a recent paper confirmed recent studies concerning the relationship between children being overweight and parents suffering high body mass indexes. High body mass indexes appear to be an important risk factor.

Anonymous Patient Answer
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