Het effect van verschillende diëten op arteriële stijfheid bij obese patiënten op liraglutide
Het effect van mediterraan, koolhydraatarm/eiwitrijk en vetarm dieet op arteriële stijfheid bij zwaarlijvige patiënten die liraglutide gebruiken: een gerandomiseerde gecontroleerde studie
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Riad El Solh
-
Beirut, Riad El Solh, Libanon, 1107 2020
- American University of Beirut - Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Mediterranean Diet
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. |
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. |
|
Experimenteel: High Protein/Low Carbohydrate Diet
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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
Tijdsspanne: 6 months after enrollment
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)
Tijdsspanne: 6 months after enrollment
|
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
|
|
Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)
Tijdsspanne: 6 months after enrollment
|
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
|
|
Body composition - percent body fat using dual x-ray absorptiometry (DXA)
Tijdsspanne: 6 months after enrollment
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dietary Assessment using 24-hour recalls
Tijdsspanne: 6 months after enrollment
|
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
|
|
Dietary Assessment using adherence questionnaires
Tijdsspanne: 6 months after enrollment
|
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
|
|
Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).
Tijdsspanne: 6 months after enrollment
|
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
|
|
Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio
Tijdsspanne: 6 months after enrollment
|
Waist and hip circumference will be measured following standard operating procedures (SOP). |
6 months after enrollment
|
|
Vital signs - blood pressure
Tijdsspanne: 6 months after enrollment
|
Blood pressure will be measured following standard operating procedures (SOP). |
6 months after enrollment
|
|
Vital signs - heart rate
Tijdsspanne: 6 months after enrollment
|
Heart rate will be measured following standard operating procedures (SOP). |
6 months after enrollment
|
|
Genetic studies
Tijdsspanne: 6 months after enrollment
|
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
|
|
Metabolic, inflammatory and appetite hormones in pg/mL
Tijdsspanne: 6 months after enrollment
|
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
|
|
Metabolic, inflammatory and appetite hormones in pmol/L
Tijdsspanne: 6 months after enrollment
|
Insulin and Ghrelin.These tests will be run at the endocrine core research Lab in batches at study completion. |
6 months after enrollment
|
|
Metabolic, inflammatory and appetite hormones in ng/mL
Tijdsspanne: 6 months after enrollment
|
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
|
|
Quality of Life Measurement as assessed by the SF-36 questionnaire
Tijdsspanne: 6 months after enrollment
|
SF-36 questionnaire filled by participant |
6 months after enrollment
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Marlene Chakhtoura, MD, MSc, American University of Beirut Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BIO-2020-0136
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .