RECRUITING

Role of Caveolin 1 (CAV-1) Deficiency in Response to Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Treatment

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

Obesity has become an important public health issue that leads to insulin resistance, diabetes, hypertension, dyslipidemia, and cardiovascular diseases. Although weight loss with calorie restriction and increased physical activity improve these complications, many people fail these lifestyle interventions. Therefore, pharmacologic agents have been used for weight management in addition to lifestyle interventions. In the past few years, one of the widely used pharmacologic agents for weight management is Glucagon-like peptide 1 receptor agonists (GLP1 RAs). Overall, this class of medications improves both metabolic and cardiovascular profiles while causing weight loss, but their effects can vary between individuals. Therefore, it is essential to understand who will respond best to this therapy. Based on previous research on the interaction between a cell membrane molecule, caveolin-1, and glucagon-like peptide 1 receptor, we hypothesize that genetic variations in the caveolin-1 gene explain the variable cardiometabolic responses.

Official Title

The Role of Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Treatment of Overweight/Obese Individuals for Improving Adverse Cardiometabolic Phenotype Associated With CAV-1 Deficiency

Quick Facts

Study Start:2023-11-01
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06069622

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years, body mass index (BMI) ≥30.0 kg/m2 or ≥27.0 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, prediabetes, dyslipidemia, obstructive sleep apnea,
  2. * Normal screening laboratory values,
  3. * Systolic BP \< 160 mmHg and diastolic BP \< 95 mmHg as determined from measurement during screening, using a random-zero device in the clinic and normal electrocardiogram, use of anti-hypertensive medications will be allowed except for mineralocorticoid receptor antagonists.
  1. * Diabetes mellitus,
  2. * Treatment with a glucose-lowering agent(s) or anti-obesity medication within 90 days of screening,
  3. * Treatment with a GLP-1 receptor agonist within 180 days,
  4. * Current treatment with beta-blocker, or steroids,
  5. * Pregnancy,
  6. * Personal history of pancreatitis,
  7. * Personal history of cholelithiasis,
  8. * Previous surgical obesity treatment,
  9. * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma,
  10. * Medical illness other than hypertension, prediabetes, obstructive sleep apnea, or dyslipidemia,
  11. * Alcohol intake \>12 oz. per week,
  12. * Tobacco, or recreational drug use

Contacts and Locations

Study Contact

Ezgi Caliskan Guzelce, M.D.
CONTACT
857-544-4290
ecaliskanguzelce@bwh.harvard.edu
Gail K.Adler, M.D.,PhD.
CONTACT
617-732-5666
gadler@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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 Date2023-11-01
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • GLP-1 receptor agonist
  • Weight loss
  • CAV-1
  • Blood pressure
  • ALDO

Additional Relevant MeSH Terms

  • Overweight and Obesity