Clinical trial NCT04990024: The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide
Official title: The Effect of Mediterranean or High Protein/Low Carbohydrate Diet on Arterial Stiffness in Non-diabetic, Obese Patients on Semaglutide: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A computer-generated allocation sequence will be used, with a permuted block randomization (1:1). The biostatistician (MB) will generate the randomization sequence and will share it with a trial coordinator (MR) who is independent of the study team. Upon the recruitment of every participant, the study RA will contact the independent trial coordinator to receive the randomization code, in an opaque and sealed envelope.

Randomization will take place at 1-30 days after starting Semaglutide. Treatment allocation will be in batches at the end of each month.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)
timeFrame: 6 months after enrollment
measure: Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)
timeFrame: 6 months after enrollment
measure: Body composition - percent body fat using dual x-ray absorptiometry (DXA)
timeFrame: 6 months after enrollment
Other outcomes:
measure: Dietary Assessment using 24-hour recalls
timeFrame: 6 months after enrollment
measure: Dietary Assessment using adherence questionnaires
timeFrame: 6 months after enrollment
measure: Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).
timeFrame: 6 months after enrollment
measure: Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio
timeFrame: 6 months after enrollment
measure: Vital signs - blood pressure
timeFrame: 6 months after enrollment
measure: Vital signs - heart rate
timeFrame: 6 months after enrollment
measure: Genetic studies
timeFrame: 6 months after enrollment
measure: Metabolic, inflammatory and appetite hormones in pg/mL
timeFrame: 6 months after enrollment
measure: Metabolic, inflammatory and appetite hormones in pmol/L
timeFrame: 6 months after enrollment
measure: Metabolic, inflammatory and appetite hormones in ng/mL
timeFrame: 6 months after enrollment
measure: Quality of Life Measurement as assessed by the SF-36 questionnaire
timeFrame: 6 months after enrollment
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
state: Riad El Solh
Study officials:
affiliation: American University of Beirut Medical Center
name: Marlene Chakhtoura, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: