Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: GLP-1, Placebo.
- Кому может быть актуально
- Состояния в реестре: Longevity, Quality of Life, Mood, Inflammation. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures: For Use in Healthy Individuals Ages 18-65 Who Seek to Improve Their Health and Longevity Through Low-dose (Microdosed) GLP1 Receptor Agonists
Обзор
The goal of this clinical study has two objectives. The Primary Objective is to evaluate the effectiveness of microdosed GLP-1 receptor agonists in improving measures of health, quality of life, and longevity. The Secondary Objective: To assess the impact of these therapies on weight management practices and metabolic health.
Подробное описание
Participants will be assigned to one of three groups: 1) control, 2) microdosed sublingual semaglutide, 3) microdosed subcutaneous semaglutide. At baseline and every 4 weeks thereafter, participants will be asked to complete surveys on health, wellness, mood, demographic information, and similar. Additionally, at baseline and every 12 weeks thereafter, they will be requested to complete evaluative blood work to measure CBC, CMP, and standard health biomarker panels (e.g., cholesterol, glucose, creatinine, sodium, potassium). From baseline throughout the duration of the study, participants will be given the option to share data from wearable activity and health trackers with the research team for greater accuracy in evaluating measures of activity, sleep, heart rate, and similar.
Вмешательства
- Препарат GLP-1
Sublingual GLP1 (weekly), Subcutaneous GLP1 (weekly), Sublingual Placebo (weekly) for up to 6 months. - Препарат Placebo
Sublingual Placebo (weekly) for up to 6 months
Первичные конечные точки
- Change in self-reported pain levels in participants microdosing GLP1s [Срок оценки: 6 months]
- Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s [Срок оценки: 6 months]
- Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s [Срок оценки: 6 months]
- Change in mood in participants microdosing GLP1s [Срок оценки: 6 months]
- Change in heart rate variability in participants microdosing GLP1s [Срок оценки: 6 months]
- Changes in sleep patterns in participants microdosing GLP1s [Срок оценки: 6 months]
- Change in frequency of physical activity in participants microdosing GLP1s [Срок оценки: 6 months]
- Change in frequency of physical activity in participants microdosing GLP1s [Срок оценки: 6 months]
Вторичные конечные точки (4)
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Срок оценки: 6 months]
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Срок оценки: 6 months]
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Срок оценки: 6 months]
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Срок оценки: 6 months]
Критерии участия
Критерии включения
- New or existing AgelessRx patient
- Adults (aged 18-65)
- Any sex
- Any ethnicity
- BMI ≥ 20 kg/m\^2
- Interest in taking microdoses of semaglutide for health and longevity improvement with no intent to seek weight loss improvement.
Критерии исключения
- Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s)
- History of bariatric surgery
- Use of other weight-loss medications currently or within the past 6 months
- Contraindications to semaglutide
- Significant psychiatric illness that may affect participation
- Pregnant or breastfeeding individuals
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- AgelessRx — Ann Arbor
Публикации
- Grieco M, Giorgi A, Gentile MC, d'Erme M, Morano S, Maras B, Filardi T. Glucagon-Like Peptide-1: A Focus on Neurodegenerative Diseases. Front Neurosci. 2019 Oct 18;13:1112. doi: 10.3389/fnins.2019.01112. eCollection 2019. PMID 31680842
- Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15. PMID 27633186
- Drucker DJ. Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1. Cell Metab. 2018 Apr 3;27(4):740-756. doi: 10.1016/j.cmet.2018.03.001. PMID 29617641
Идентификаторы
NCT: NCT07092605 · ALRx010