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

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Dietary Intervention Med Diet
Dietary Intervention HP/LC Diet
Dietary Intervention LF Diet
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • American University of Beirut - Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mediterranean Diet

High protein/Low Carbohydrate Diet

Low Fat Diet

Arm Description

50 participants will be randomized to this arm. The intervention consists of 5 individual (visits 1,3,5,7,9) and 8 group (visits 1,2,3,4,5,6,7,8) educational sessions on Mediterranean diet in patients on Liraglutide, over a period of 24 weeks. Dietary assessments and adherence questionnaires will be held on several visits to assess adherence.

50 participants will be randomized to this arm. The intervention consists of 5 individual (visits 1,3,5,7,9) and 8 group (visits 1,2,3,4,5,6,7,8) educational sessions on HP/LC diet in patients on Liraglutide, over a period of 24 weeks. Dietary assessments and adherence questionnaires will be held on several visits to assess adherence.

50 participants will be randomized to this arm. The intervention consists of 5 individual (visits 1,3,5,7,9) and 8 group (visits 1,2,3,4,5,6,7,8) educational sessions on low fat diet in patients on Liraglutide, over a period of 24 weeks. Dietary assessments and adherence questionnaires will be held on several visits to assess adherence.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 2, 2021
Last Updated
July 19, 2022
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04990024
Brief Title
The Effect of Different Diets on Arterial Stiffness in Obese Patients on Liraglutide
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A computer-generated allocation sequence will be used, with a permuted block randomization (1:1:1). 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 Liraglutide. Treatment allocation will be in batches at the end of each month, and therefore allows for group sessions.
Masking
None (Open Label)
Masking Description
The design is open label as it is impossible to blind the participants and the research team for the study intervention. Each of the dietary interventions will be delivered in the format of intensive, individual and group sessions about the diet, food selection and food recipes.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
50 participants will be randomized to this arm. The intervention consists of 5 individual (visits 1,3,5,7,9) and 8 group (visits 1,2,3,4,5,6,7,8) educational sessions on Mediterranean diet in patients on Liraglutide, over a period of 24 weeks. Dietary assessments and adherence questionnaires will be held on several visits to assess adherence.
Arm Title
High protein/Low Carbohydrate Diet
Arm Type
Experimental
Arm Description
50 participants will be randomized to this arm. The intervention consists of 5 individual (visits 1,3,5,7,9) and 8 group (visits 1,2,3,4,5,6,7,8) educational sessions on HP/LC diet in patients on Liraglutide, over a period of 24 weeks. Dietary assessments and adherence questionnaires will be held on several visits to assess adherence.
Arm Title
Low Fat Diet
Arm Type
Active Comparator
Arm Description
50 participants will be randomized to this arm. The intervention consists of 5 individual (visits 1,3,5,7,9) and 8 group (visits 1,2,3,4,5,6,7,8) educational sessions on low fat diet in patients on Liraglutide, over a period of 24 weeks. Dietary assessments and adherence questionnaires will be held on several visits to assess adherence.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention Med Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention HP/LC Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention LF Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
Description
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.
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)
Description
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.
Time Frame
6 months after enrollment
Title
Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)
Description
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.
Time Frame
6 months after enrollment
Title
Body composition - percent body fat using dual x-ray absorptiometry (DXA)
Description
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.
Time Frame
6 months after enrollment
Other Pre-specified Outcome Measures:
Title
Dietary Assessment using 24-hour recalls
Description
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.
Time Frame
6 months after enrollment
Title
Dietary Assessment using adherence questionnaires
Description
During the individual sessions, brief adherence assessment questionnaires for each diet, adapted from PREDIMED protocol, will be administered to calculate dietary adherence scores.
Time Frame
6 months after enrollment
Title
Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).
Description
Weight and height will be measured following standard operating procedures (SOP) and BMI will be computed by dividing weight by height squared.
Time Frame
6 months after enrollment
Title
Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio
Description
Waist and hip circumference will be measured following standard operating procedures (SOP).
Time Frame
6 months after enrollment
Title
Vital signs - blood pressure
Description
Blood pressure will be measured following standard operating procedures (SOP).
Time Frame
6 months after enrollment
Title
Vital signs - heart rate
Description
Heart rate will be measured following standard operating procedures (SOP).
Time Frame
6 months after enrollment
Title
Genetic studies
Description
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.
Time Frame
6 months after enrollment
Title
Metabolic, inflammatory and appetite hormones in pg/mL
Description
Gastric inhibitory polypeptide (GIP), Leptin, Adiponectin, Orexin, IL6. These tests will be run at the endocrine core research Lab in batches at study completion.
Time Frame
6 months after enrollment
Title
Metabolic, inflammatory and appetite hormones in pmol/L
Description
Insulin and Ghrelin.These tests will be run at the endocrine core research Lab in batches at study completion.
Time Frame
6 months after enrollment
Title
Metabolic, inflammatory and appetite hormones in ng/mL
Description
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.
Time Frame
6 months after enrollment
Title
Quality of Life Measurement as assessed by the SF-36 questionnaire
Description
SF-36 questionnaire filled by participant
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlene Chakhtoura, MD, MSc
Phone
+9611350000
Ext
7411
Email
mc39@aub.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Rachelle El Haber, BSc
Phone
+9611350000
Ext
8314
Email
re136@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Chakhtoura, MD, MSc
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut - Medical Center
City
Beirut
State/Province
Riad El Solh
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AUBMC
Phone
+961350000
Email
aubmc@aub.edu.lb
First Name & Middle Initial & Last Name & Degree
Marlene Chakhtoura, MD, MSc

12. IPD Sharing Statement

Learn more about this trial

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

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