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

NCT04990024 | Recruiting DMC

• 1 other identifier: BIO-2020-0136
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)

  6 months after enrollment

• Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)

  6 months after enrollment

• Body composition - percent body fat using dual x-ray absorptiometry (DXA)

  6 months after enrollment

Other Outcomes (11)

• Dietary Assessment using 24-hour recalls

  6 months after enrollment

• Dietary Assessment using adherence questionnaires

  6 months after enrollment

• Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).

  6 months after enrollment

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

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.

Other: Dietary Intervention Med Diet

High Protein/Low Carbohydrate Diet

EXPERIMENTAL

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.

Other: Dietary Intervention HP/LC Diet

Interventions

Dietary Intervention Med Diet OTHER

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.

Mediterranean Diet

Dietary Intervention HP/LC Diet OTHER

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.

High Protein/Low Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Riad El Solh, 1107 2020, Lebanon

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Marlene Chakhtoura, MD, MSc

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlene Chakhtoura, MD, MSc

CONTACT

+9611350000; mc39@aub.edu.lb

Rachelle El Haber, BSc

CONTACT

+9611350000; re136@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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 sessions about the diet, food selection and food recipes. Outcome assessors will be blind to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 4, 2021
• Study Start: July 1, 2021
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

LE (1)