RECRUITING

Weight Loss Study: Genetics and Response to Naltrexone/Bupropion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\[s\] it aims to answer are: * In Aim One, the investigators propose to rigorously test the hypothesis that presence of the Taq1A A1+ polymorphism is associated with greater weight loss with NB compared with the A1- genotype. * In Aim Two, the investigators will explore other genetic polymorphisms that might influence the efficacy of NB such as the fat mass and obesity-associated (FTO) gene which modulates DRD2 signaling, as carriers of risk alleles in both the FTO and ANKK1 gene demonstrate altered responses to reward-learning tasks associated with negative outcomes. Participants will be in the study for 40 weeks, which consists of two phases: 1. From baseline to week 12, participants will receive individual nutritional counseling on a calorie restricted diet. This phase includes in-person visits, blood tests, an EKG, vital signs, questionnaires, body weight, and nutritional visits. 2. From week 12 to week 40, participants will continue to receive dietary counseling and will receive treatment with naltrexone/bupropion for 28 weeks. This phase includes in-person and phone visits, blood tests, vital signs, questionnaires, body weight, and nutritional visits.

Official Title

Association of Genetic Variations and Weight Loss Response to Naltrexone/Bupropion

Quick Facts

Study Start:2023-06-08
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05919797

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women ages 18-65 years
  2. * BMI 30-50 kg/m2 or
  3. * BMI 27-29.99 kg/m2 with at least one weight-related comorbidity including controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint.
  1. * Obesity of known endocrine or hypothalamic origin
  2. * HbA1c \> 6.5%
  3. * Cerebrovascular, cardiovascular, hepatic or renal disease
  4. * History of seizures, serious psychiatric illness or suicide attempts, drug or alcohol misuse within prior 24 months
  5. * Glaucoma
  6. * Current tobacco use on a regular basis
  7. * Use of dopamine agonists, opioid analgesics, antipsychotics, antidepressants, neuroleptics, naltrexone, diabetes medications
  8. * Use of Monoamine oxidase (MAO) inhibitors \< 14 days prior to screening
  9. * Concomitant use of CYP2B6 inhibitors
  10. * History of anorexia nervosa or bulimia
  11. * Previous surgery for obesity
  12. * Weight loss device intervention within prior 2 years
  13. * Currently pregnant or lactating, planning pregnancy or refusal to use birth control when appropriate (Women of childbearing potential will be required to use effective contraception.)
  14. * Blood pressure \> 145/95 (use of anti-hypertensives will be allowed with the exception of verapamil, which can cause hyperprolactinemia)
  15. * Clinically significant thyroid disease
  16. * Triglycerides \> 499 mg/dl
  17. * Current use or use of weight loss medication within prior six months
  18. * Any lifetime weight change deemed significant by Principal Investigator
  19. * An affirmative answer to any question in the Columbia-Suicide Severity Rating Scale

Contacts and Locations

Study Contact

Judith Korner, MD,PhD
CONTACT
212-305-4006
jk181@cumc.columbia.edu
Sarah Borden, MPH
CONTACT
212-305-4006
sb1097@cumc.columbia.edu

Principal Investigator

Judith Korner, MD,PhD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Judith Korner, MD,PhD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Weight loss

Additional Relevant MeSH Terms

  • Obesity