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Идёт набор NCT06547515

Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women

— Наблюдательное Bariatric Surgery Bone Health Severe Obesity Muscle Health

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: Bariatric surgery.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery, Bone Health, Severe Obesity, Muscle Health. Базовые параметры: от 18 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.

Вмешательства

  • Процедура Bariatric surgery
    Sleeve gastrectomy

Первичные конечные точки

  • Change in vBMD at the spine (L2-L3) and proximal femur [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in muscle mass at mid-femur [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
Вторичные конечные точки (9)
  • Change in vBMD at skeletal sites other than the spine [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in aBMD at skeletal sites [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in whole body muscle mass [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in muscle quality at mid-femur [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in muscle strength [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in upper extremity muscle strength [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in lower extremity muscle strength [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in muscle mass (muscle cross-sectional area) and function [Срок оценки: before, 1 year after and 3 years after bariatric surgery]
  • Change in muscle mass (muscle cross-sectional area) and function [Срок оценки: before, 1 year after and 3 years after bariatric surgery]

Критерии участия

Критерии включения

  • Men and women aged >18 years;
  • Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.
  • Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) >40 UI/L.
  • Women taking oral contraceptive pills or hormone replacement therapy
  • Patients with type 2 diabetes.

Критерии исключения

  • Type 1 diabetes;
  • Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
  • Metabolic bone disease other than osteoporosis or type 2 diabetes,
  • Creatinine clearance <30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
  • Weight >204 kg (DXA weight limit) or BMI >60 kg/m2 (upper limit to allow for QCT examination);
  • Current or planned pregnancy during follow-up; breast-feeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Centre de recherche de l'IUCPQ — Québec

Идентификаторы

NCT: NCT06547515 · MP-10-2022-3823

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗