Is NCT07090005 recruiting in Orlando, FL?

Yes, NCT07090005 is currently recruiting participants at its Orlando, FL location. This obesity clinical trial is actively enrolling qualified participants.

How do I join the obesity clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Obesity Clinical Trial in Orlando, FL

Who Can Participate

Inclusion Criteria

BMI ≥ 30 and ≤50 kg/m².

Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.

History of failure with non-surgical weight-loss methods.

Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing IWQOL questionnaire and completing the medically supervised diet and behavior modification program.

Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.

Ability to give informed consent.

Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.

There will be a quota for at least a) 46 patients with hypertension treated with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment , b) 46 patients with type II diabetes mellitus on oral agents only with HgbA1c ≤ 9 at least 6 months prior to study enrollment, excluding Insulin-dependent. Thus the cohort of 184 patients will be stratified into four groups (Obesity, Obesity \& HTN, Obesity \& DM, obesity \&HTN \&DM) and block randomized.

Exclusion Criteria

History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)

Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.

Prior open or laparoscopic bariatric surgery.

Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.

Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.

Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.

A gastric mass or gastric polyps \> 1 cm in size.

A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.

A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.

Achalasia or any other severe esophageal motility disorder

Severe coagulopathy (INR \>1.5) or on anticoagulation therapy.

Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C ≥ \> 9.

Diabetics who are treated with GLP-1 and have lost 5% or more of their weight (%TBWL ≥ 5%).

Patients who discontinued GLP-1 therapy and regained less than 80% of the weight they had lost prior to starting GLP-1 treatment and within 3 months of discontinued GLP-1 therapy.

Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy

Chronic abdominal pain

Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation

Hepatic insufficiency or cirrhosis

Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.

Active psychological issues preventing participation in a life-style modification program as determined by a psychologist

Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.

Patients receiving daily prescribed treatment with high dose aspirin (\> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.

Patients who are unable or unwilling to take prescribed proton pump inhibitor medication

Patients who are pregnant or breast-feeding.

Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs

Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti- arrhythmic medications

Patients who are taking corticosteroids, immunosuppressants, and narcotics

Patients who are taking diet pills

Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.

Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.

Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.

Specific diagnosed genetic disorder such as Prader Willi syndrome.

Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating

Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07090005) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obesity Treatment Options in Orlando, FL

If you're searching for obesity treatment options in Orlando, FL, this clinical trial (NCT07090005) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obesity specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obesity clinical trials near you to find additional studies recruiting in your area.

Obesity Clinical Trial in Orlando, FL

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