Pharmacological and Behavioral Treatment After Bariatric Surgery

Launched by YALE UNIVERSITY · Dec 5, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at different ways to help people who have had weight-loss surgery, specifically focusing on how effective behavioral treatments (like counseling and support) and medication can be for improving weight loss, heart health, and mental well-being. The study will compare these treatments alone and together to see which works best after surgery for obesity.

To participate, you need to be between 18 and 75 years old, have a Body Mass Index (BMI) of 30 or higher (or 27 with certain health issues), and have had specific types of weight-loss surgery in the past. You'll need to be willing to commit to the study for up to 18 months, including a 6-month treatment period and a 12-month follow-up. Participants can expect regular check-ins and support as they work towards their health goals. It's important to note that there are some health conditions and medications that could prevent someone from joining, so discussing your situation with your doctor is crucial.

Gender

ALL

Eligibility 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