The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide

American University of Beirut Medical Center

Status: Enrolling

Conditions: Weight Loss; Obesity

Treatments: Other: Dietary Intervention Med Diet; Other: Dietary Intervention HP/LC Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04990024

BIO-2020-0136

Details and patient eligibility

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.

Full description

This is a 6-month open label pilot RCT that will be conducted on Lebanese subjects with obesity, upon the initiation of Semaglutide for medical weight management, as recommended by their physician. Patients will be randomized to 2 treatment arms: Med diet and HP/LC diet. Med diet will be hypocaloric, allowing the same energy restriction, of 500 Kcal/d, while the HP/LC diet will be ad libitum. Participants will be recruited from the Endocrine clinics at AUB-MC, and from satellite clinic next in Beirut. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mediterranean Diet

Experimental group

Description:

30 participants will be randomized to this arm. The intervention consists of 8 visits, over a period of 24 weeks, including 6 individual educational sessions on Mediterranean diet in patients on Semaglutide and 2 reinforcement educational sessions towards the end of the trial. Dietary assessments and adherence questionnaires will be conducted on several visits to assess adherence.

Treatment:

Other: Dietary Intervention Med Diet

High Protein/Low Carbohydrate Diet

Experimental group

Description:

30 participants will be randomized to this arm. The intervention consists of 8 visits, over a period of 24 weeks, including 6 individual educational sessions on High Protein/Low Carbohydrate diet in patients on Semaglutide and 2 reinforcement educational sessions towards the end of the trial. Dietary assessments and adherence questionnaires will be conducted on several visits to assess adherence.

Treatment:

Other: Dietary Intervention HP/LC Diet