Vliv různých diet na arteriální ztuhlost u obézních pacientů na liraglutid
Vliv středomořské, nízkosacharidové/vysokoproteinové a nízkotučné diety na arteriální ztuhlost u obézních pacientů na liraglutidu: Randomizovaná kontrolovaná 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Riad El Solh
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Beirut, Riad El Solh, Libanon, 1107 2020
- American University of Beirut - Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
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Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
cfPWV measurement and pulse wave analysis (PWA) using SphygmoCorCvMS V9 (AtCor Medical)
Časové okno: 6 months after enrollment
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body composition - visceral adipose tissue using dual x-ray absorptiometry (DXA)
Časové okno: 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
|
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Body composition - percent fat-free body mass using dual x-ray absorptiometry (DXA)
Časové okno: 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
|
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Body composition - percent body fat using dual x-ray absorptiometry (DXA)
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dietary Assessment using 24-hour recalls
Časové okno: 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
|
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Dietary Assessment using adherence questionnaires
Časové okno: 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
|
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Anthropometric measurements - weight in kilograms, height in centimetres, aggregated into BMI (kilogram per meter squared).
Časové okno: 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
|
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Anthropometric measurements - waist and hip circumference in centimetres, aggregated into waist to hip ratio ratio
Časové okno: 6 months after enrollment
|
Waist and hip circumference will be measured following standard operating procedures (SOP). |
6 months after enrollment
|
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Vital signs - blood pressure
Časové okno: 6 months after enrollment
|
Blood pressure will be measured following standard operating procedures (SOP). |
6 months after enrollment
|
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Vital signs - heart rate
Časové okno: 6 months after enrollment
|
Heart rate will be measured following standard operating procedures (SOP). |
6 months after enrollment
|
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Genetic studies
Časové okno: 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
|
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Metabolic, inflammatory and appetite hormones in pg/mL
Časové okno: 6 months after enrollment
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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
|
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Metabolic, inflammatory and appetite hormones in pmol/L
Časové okno: 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
|
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Metabolic, inflammatory and appetite hormones in ng/mL
Časové okno: 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
|
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Quality of Life Measurement as assessed by the SF-36 questionnaire
Časové okno: 6 months after enrollment
|
SF-36 questionnaire filled by participant |
6 months after enrollment
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Marlene Chakhtoura, MD, MSc, American University of Beirut Medical Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BIO-2020-0136
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