The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide
Recruiting · NCT04990024 · Interventional (participants receive a specific treatment) · Lead sponsor: American University of Beirut Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Dietary Intervention HP/LC DietDietary Intervention Med Diet
What this trial is about
In patients initiating Semaglutide for weight management, the objective is to compare the effect of the Mediterranean diet and the high protein/low carbohydrate (HP/LC) diet CV parameters, namely arterial stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), and visceral adipose tissue, in addition to other metabolic indicators.
Who can take part
Age range
18 Years to 49 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men and premenopausal women, 18-49 years, with obesity defined as BMI ≥ 30 kg/m2
- Upon the initiation of Semaglutide (within the first 1-4 weeks) for medical weight management, for clinical purposes, as advised by the primary physician
- Able to commit for a 6-month trial visits
Exclusion criteria
- Pregnant women
- Patients who are taking or have taken other weight reducing drug therapies in the previous 6 months
- Patients who have undergone metabolic weight loss surgery
- Patients known to have diabetes (HbA1c ≥6.5% at screening)
- Patients with uncontrolled hypertension
- Patients with uncontrolled cardiac disease, pulmonary, renal or liver diseases, active cancer or psychiatric diseases
- Patients with excessive alcohol intake, defined as ≥ 2 glasses per day
- Patients known to have uncontrolled/ untreated thyroid disorders.
- Patients with cushing disease or polycystic ovaries, and those with neuro-endocrine or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy): Such patients are resistant to weight loss, and they need treatment of their primary disease and/or cessation of the culprit medication to lose weight
- Patients with untreated gout
- Patients who have undergone bariatric surgery
Where it is running
1 location listed.
- American University of Beirut - Medical Center - Beirut, Riad El Solh, Lebanon