Comparing treatments for weight loss after bariatric surgery
Behavioral and Pharmacological Treatments to Enhance Weight Outcomes After Metabolic and Bariatric Surgery
This study is testing whether a combination of a weight loss program and a medication can help people who have had bariatric surgery lose more weight and improve their overall health.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05157698 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of behavioral and pharmacological treatments, both individually and in combination, to improve weight loss, cardiovascular health, and psychosocial well-being in patients who have undergone metabolic and bariatric surgery. It employs a randomized double-blind placebo-controlled design to assess the impact of a manualized behavioral weight loss program and an FDA-approved medication (naltrexone+bupropion) on patients with suboptimal weight outcomes. The study aims to generate new clinical insights that could enhance management strategies for obesity following surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals with a BMI between 30 and 50 who have undergone laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy and are experiencing suboptimal weight loss.
Not a fit: Patients who have not had bariatric surgery or those with uncontrolled medical problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved weight loss and overall health outcomes for patients struggling with obesity after bariatric surgery.
How similar studies have performed: Previous studies have shown promise in combining behavioral and pharmacological approaches for obesity treatment, suggesting potential success for this study's methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study (up to 18 months: 6-month treatment plus 12-month follow up) * Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2 * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy * Suboptimal weight outcomes after MBS * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies). * Have had a physical in the past year * Read, comprehend, and write English at a sufficient level to complete study-related materials. * For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: * Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold). * Has a history of anorexia nervosa or history of bulimia nervosa. * Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates). * Is currently using other medications for weight loss. * Has a history of allergy or sensitivity to bupropion or naltrexone. * Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression) * Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute. * Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke. * Has current uncontrolled hypertension. * Has current uncontrolled Type I or Type 2 diabetes mellitus. * Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit. * Has gallbladder disease. * Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder. * Has a recent history of drug or alcohol dependence. * Is currently in active effective treatment for eating or weight loss such as behavioral weight loss of FDA-approved weight loss medications. * Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. * Is breast-feeding or is pregnant or is not using a reliable form of birth control. * Reports active suicidal or homicidal ideation. * Has poor eye health
Where this trial is running
New Haven, Connecticut
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Valentina Ivezaj, Ph.D. — Yale University
- Study coordinator: Valentina Ivezaj, Ph.D.
- Email: valentina.ivezaj@yale.edu
- Phone: 203-785-7210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.