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

Obesity Clinical Trial

Official title:

The Effect of Mediterranean, Low Carbohydrate/High Protein and Low-fat Diet on Arterial Stiffness in Obese Patients on Liraglutide: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990024
• Other study ID #: BIO-2020-0136
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: July 2022
• Source: American University of Beirut Medical Center
• Contact: Marlene Chakhtoura, MD, MSc
• Phone: +9611350000
• Email: mc39[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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 group educational sessions on Med diet. During the group 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.
• 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 group educational sessions on HP/LC, same as with Med diet (above). The individual sessions with subjects will also allow to individualize the diet plan.
• Dietary Intervention LF Diet
In this arm, participants will be advised to follow a calorie restricted LF diet with 500 Kcal/d energy restriction. Group and individual educational sessions will be held at the same frequency as the Med and HP/LC diets, and will have a similar content but targeting LF diet.

Locations

Country	Name	City	State
Lebanon	American University of Beirut - Medical Center	Beirut	Riad El Solh

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary Assessment using 24-hour recalls	Three-repeated 24-hour recalls (24 HR) administered via phone (2-week days and one week-end day, during one specific week). During the phone call, the participant will be asked to recall all what she/he has consumed during the past 24 hours, and the multiple pass approach of the USDA will be adopted.	6 months after enrollment
Other	Dietary Assessment using adherence questionnaires	During the individual sessions, brief adherence assessment questionnaires for each diet, adapted from PREDIMED protocol, will be administered to calculate dietary adherence scores.	6 months after enrollment
Other	Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).	Weight and height will be measured following standard operating procedures (SOP) and BMI will be computed by dividing weight by height squared.	6 months after enrollment
Other	Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio	Waist and hip circumference will be measured following standard operating procedures (SOP).	6 months after enrollment
Other	Vital signs - blood pressure	Blood pressure will be measured following standard operating procedures (SOP).	6 months after enrollment
Other	Vital signs - heart rate	Heart rate will be measured following standard operating procedures (SOP).	6 months after enrollment
Other	Genetic studies	Genetic studies will consist of Single Nucleoside Polymorphism (SNP) analysis of genes of the GLP1 receptors and cannabinoid receptor 1 will be performed in the molecular lab. These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Other	Metabolic, inflammatory and appetite hormones in pg/mL	Gastric inhibitory polypeptide (GIP), Leptin, Adiponectin, Orexin, IL6. These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Other	Metabolic, inflammatory and appetite hormones in pmol/L	Insulin and Ghrelin.These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Other	Metabolic, inflammatory and appetite hormones in ng/mL	Irisin and mineral hormones and markers, including Crosslaps, Osteocalcin, GLP1. These tests will be run at the endocrine core research Lab in batches at study completion.	6 months after enrollment
Other	Quality of Life Measurement as assessed by the SF-36 questionnaire	SF-36 questionnaire filled by participant	6 months after enrollment
Primary	cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)	Measured by an RA or a technician, based on the American Heart Association Council recommendations on arterial stiffness measurement in research. The distance from the suprasternal notch to the carotid pulse, and to the femoral site on the same side will be measured; the former distance is subtracted from the latter one. Ten seconds of carotid and 10 seconds of femoral arterial waveforms will be recorded, and the average of the data will be obtained for each of the sites.	6 months after enrollment
Secondary	Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)	Measured by an RA or a technician, assessed using dual x-ray absorptiometry (DXA), Hologic machine, version 13.6.0.5, the preferred method for the assessment of body composition. The ISCD recommendations will be followed for body composition measurement.	6 months after enrollment
Secondary	Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)	Measured by an RA or a technician, assessed using dual x-ray absorptiometry (DXA), Hologic machine, version 13.6.0.5, the preferred method for the assessment of body composition. The ISCD recommendations will be followed for body composition measurement.	6 months after enrollment
Secondary	Body composition - percent body fat using dual x-ray absorptiometry (DXA)	Measured by an RA or a technician, assessed using dual x-ray absorptiometry (DXA), Hologic machine, version 13.6.0.5, the preferred method for the assessment of body composition. The ISCD recommendations will be followed for body composition measurement.	6 months after enrollment