Understanding how caveolin-1 deficiency affects weight loss with GLP-1 receptor agonists

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.