Overview
In patients initiating Liraglutide for weight management, the objective is to compare the effect of Med diet, high protein/low carbohydrate (HP/LC) diet and low fat (LF) control diet on CV parameters, namely arterial stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), and visceral adipose tissue, in addition to other metabolic indicators.
Description
This is a 6-month open label pilot RCT that will be conducted on Lebanese participants with obesity, upon the initiation of Liraglutide for medical weight management, as recommended by their physician. Patients will be randomized to 3 treatment arms: Mediterranean (Med) diet, high protein/ low carbohydrate (HP/LC) diet, and control low fat (LF) diet. While both Med diet and LF diet will be both hypocaloric, allowing the same energy restriction, of 500 Kcal/d, the HP/LC diet will be ad libitum. Participants will be recruited from the Endocrine clinics at AUB-MC (in Building 23 and at the Metabolic and Bariatric Surgery Unit), and from satellite clinics next to AUB- MC. Brochures and posters of the trial will be available in the clinic waiting areas. Patients of both participating and non-participating physicians will be recruited in the study.
Eligibility
Inclusion Criteria:
- Men and premenopausal women with obesity defined as BMI ≥ 30 kg/m2
- Upon the initiation of Liraglutide (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 cardiac, 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