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

Overview

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.

Interventions

• Other Dietary Intervention Med Diet
  The diet will consist of a calorie-restricted Med diet, with 500 Kcal/d energy restriction. The intervention consists of individual and reinforcement sessions on Med diet. During these sessions, the RA will go over the benefits of Med diet, what composition it should have, and how to make appropriate choices for meal planning, in addition to providing food lists, by season. The individual sessions with subjects will also allow to individualize the diet plan.
• Other Dietary Intervention HP/LC Diet
  This is a non-ketogenic diet consisting of ad libitum intake of proteins, fat, and vegetables, with restriction of daily carbohydrates to \<130 g/d. The intervention consists of individual and reinforcement educational sessions on HP/LC, same as with Med diet (above). The individual sessions with subjects will also allow to individualize the diet plan.

Primary outcome measures

• cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical) [Time frame: 6 months after enrollment]

Secondary outcome measures (3)

• Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA) [Time frame: 6 months after enrollment]
• Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA) [Time frame: 6 months after enrollment]
• Body composition - percent body fat using dual x-ray absorptiometry (DXA) [Time frame: 6 months after enrollment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Lebanon · 1 center

• American University of Beirut - Medical Center — Beirut

Identifiers

NCT: NCT04990024 · BIO-2020-0136

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗