Understanding how caveolin-1 deficiency affects weight loss with GLP-1 receptor agonists
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
This study is trying to see how a lack of caveolin-1 affects weight loss in overweight and obese adults using a specific weight loss medication called GLP-1 receptor agonists.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06069622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of caveolin-1 deficiency in the response to glucagon-like peptide 1 receptor agonist treatment for weight management in overweight and obese adults. It focuses on understanding the mechanisms behind variable blood pressure responses and weight loss outcomes associated with GLP-1 receptor agonists. Participants will undergo 24-hour ambulatory blood pressure monitoring and follow a liberal salt diet to assess their responses. The study will include individuals with a BMI of 30 or greater or 27 with weight-related comorbidities, while excluding those with diabetes or recent treatments affecting weight management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI of 30 or greater or 27 with weight-related comorbidities such as hypertension or dyslipidemia.
Not a fit: Patients with diabetes or those who have recently used glucose-lowering or anti-obesity medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which patients are most likely to benefit from GLP-1 receptor agonist therapy for weight loss and related health improvements.
How similar studies have performed: Previous studies have shown varying responses to GLP-1 receptor agonists, but this specific investigation into caveolin-1's role is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, * Normal screening laboratory values, * 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. Exclusion Criteria: * Diabetes mellitus, * Treatment with a glucose-lowering agent(s) or anti-obesity medication within 90 days of screening, * Treatment with a GLP-1 receptor agonist within 180 days, * Current treatment with beta-blocker, or steroids, * Pregnancy, * Personal history of pancreatitis, * Personal history of cholelithiasis, * Previous surgical obesity treatment, * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, * Medical illness other than hypertension, prediabetes, obstructive sleep apnea, or dyslipidemia, * Alcohol intake \>12 oz. per week, * Tobacco, or recreational drug use
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Ezgi Caliskan Guzelce, M.D.
- Email: ecaliskanguzelce@bwh.harvard.edu
- Phone: 857-544-4290
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.