Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access (PIVOT)
Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.
The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.
The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
Контакты исследования
- Имя: Heather LaPier
- Номер телефона: 65373 519-646-6100
- Электронная почта: heather.lapier@sjhc.london.on.ca
Места учебы
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Ontario
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London, Ontario, Канада
- London Health Sciences Centre
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Контакт:
- Heather LaPier, MD
- Номер телефона: 65373 519-646-6100
- Электронная почта: heather.lapier@sjhc.london.on.ca
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London, Ontario, Канада, N6A4V2
- St. Joseph's Health Care
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Контакт:
- Heather LaPier
- Номер телефона: 65373 519-646-6100
- Электронная почта: heather.lapier@sjhc.london.on.ca
-
-
Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 18 years or older
- BMI >35 kg/m2
- eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater
Exclusion Criteria:
- Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)
- Type 1 diabetes
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
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Экспериментальный: Virtual Weight Management Program
A maximum tolerated dose of semaglutide will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months. |
Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.
Другие имена:
Virtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.
Другие имена:
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Без вмешательства: Usual Care
Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Body Weight
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts) |
Baseline to 26 weeks +/- 14 days
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in Kidney Disease Quality of Life (KDQOL-36) score across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life. |
Baseline to 26 weeks +/- 14 days
|
|
Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in health-related quality of life measured using the European Quality of Life 5-Dimension, 5-Level questionnaire across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst). |
Baseline to 26 weeks +/- 14 days
|
|
Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in functional status measured with KDQOL-36™ scores across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life. |
Baseline to 26 weeks +/- 14 days
|
|
Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Measured via EQ-5D-5L (European Quality of Life five-dimensional, five-level generic measure) scores across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst). |
Baseline to 26 weeks +/- 14 days
|
|
Weight Loss ≥5%
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of participants achieving at least 5% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
|
|
Weight Loss ≥10%
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of participant achieving at least 10% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
|
|
Weight Loss ≥15%
Временное ограничение: 26 weeks +/- 14 days
|
Percentage of participants achieving at least 15% reduction in body weight from baseline. |
26 weeks +/- 14 days
|
|
Weight Loss ≥20%
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of participants achieving at least 20% reduction in body weight from baseline. |
Baseline to 26 weeks +/- 14 days
|
|
Body Mass Index (BMI)
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in BMI across treatment arms. Measured in kg/m² |
Baseline to 26 weeks +/- 14 days
|
|
Body Surface Area (BSA)
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in BSA across treatment arms. Measured in m². |
Baseline to 26 weeks +/- 14 days
|
|
Body Mass Index <35 kg/m²
Временное ограничение: Week 26 +/- 14 days
|
Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing. |
Week 26 +/- 14 days
|
|
Dalhousie Clinical Frailty Scale Rating
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in Dalhousie Clinical Frailty Scale rating across treatment arms. The scale ranges from 1 (very fit) to 9 (terminally ill). |
Baseline to 26 weeks +/- 14 days
|
|
SARC-F Score
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in sarcopenia measured by SARC-F score across treatment arms. This questionnaire is scored out of 10, with a score of 4 or higher indicating probable sarcopenia. |
Baseline to 26 weeks +/- 14 days
|
|
FRAIL Scale
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in frailty measured by the FRAIL Scale across treatment arms. The scale scores five components - fatigue, resistance, ambulation, illnesses, and loss of weight - on a 0-5 scale, with 0 indicating robust, 1-2 pre-frail, and 3 or more indicating frailty. |
Baseline to 26 weeks +/- 14 days
|
|
Acute Kidney Injury (AKI)
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants |
Baseline to 26 weeks +/- 14 days
|
|
Hypoglycemia
Временное ограничение: Baseline to week 26 +/- 14 days
|
Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring) |
Baseline to week 26 +/- 14 days
|
|
Gastrointestinal Symptoms
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation |
Baseline to 26 weeks +/- 14 days
|
|
Acute Biliary Disease
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of acute biliary disease. |
Baseline to 26 weeks +/- 14 days
|
|
Acute Pancreatitis
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of acute pancreatitis. |
Baseline to 26 weeks +/- 14 days
|
|
Diabetic Retinopathy Interventions
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of interventions for diabetic retinopathy |
Baseline to 26 weeks +/- 14 days
|
|
Injection-site reactions
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of injection-site reactions in the intervention arm. |
Baseline to 26 weeks +/- 14 days
|
|
Malignant Neoplasms
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Incidence of malignant neoplasms. |
Baseline to 26 weeks +/- 14 days
|
|
Coaching Visit Adherence
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of participants completing ≥4 of 6 coaching visits. |
Baseline to 26 weeks +/- 14 days
|
|
Semaglutide Discontinuation
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of participants discontinuing semaglutide in the intervention arm. |
Baseline to 26 weeks +/- 14 days
|
|
Achievement of semaglutide dose ≥1.0 mg/week
Временное ограничение: Week 26 +/- 14 days
|
Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week. |
Week 26 +/- 14 days
|
|
Achievement of Semaglutide Dose ≥2.0 mg/week
Временное ограничение: 26 weeks +/- 14 days
|
Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week |
26 weeks +/- 14 days
|
|
Semaglutide Initiation in Usual Care
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of usual care arm participants initiating semaglutide during the study period. |
Baseline to 26 weeks +/- 14 days
|
|
Use of Semaglutide in Usual Care Participants
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Percentage of participants using semaglutide in the usual care arm. |
Baseline to 26 weeks +/- 14 days
|
|
Semaglutide Dose ≥1.0 mg/Week in Usual care Arm
Временное ограничение: 26 weeks +/- 14 days
|
Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week |
26 weeks +/- 14 days
|
|
Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm
Временное ограничение: 26 Weeks +/- 14 days
|
Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week |
26 Weeks +/- 14 days
|
|
Body Fat Percentage Measured with Smart Scale
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Change in body fat percentage among the subsample of intervention participants using the study smart scale. |
Baseline to 26 weeks +/- 14 days
|
|
Muscle Mass Measured with Smart Scale
Временное ограничение: Baseline to 26 weeks +/- 14 days
|
Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale. |
Baseline to 26 weeks +/- 14 days
|
|
Intervention Costs
Временное ограничение: Baseline to 26 weeks
|
The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD) |
Baseline to 26 weeks
|
|
Out-of-pocket costs
Временное ограничение: Baseline to 26 weeks
|
Total out-of-pocket costs incurred by participants during the 26-week study period-including costs directly related to the intervention. Measured in Canadian dollars (CAD) |
Baseline to 26 weeks
|
|
Lost Productivity Costs
Временное ограничение: Baseline to 26 weeks
|
Costs associated with productivity losses during the 26-week follow-up period, including costs directly related to the participant's health care and intervention. Measured in Canadian dollars (CAD) |
Baseline to 26 weeks
|
|
Health care utilization costs
Временное ограничение: Baseline to 26 weeks
|
Total costs associated with health care utilization during the study period, including physician visits, hospitalizations, emergency department visits, medications, allied health services. Measured in Canadian dollars (CAD) using provincial administrative health data. |
Baseline to 26 weeks
|
Другие показатели результатов
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in HbA1c
Временное ограничение: Baseline to 24 Months
|
Change in glycated hemoglobin among participants with diabetes across treatment arms. |
Baseline to 24 Months
|
|
Hospitalization for Hyperglycemia
Временное ограничение: Baseline to 24 Months
|
Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms |
Baseline to 24 Months
|
|
Hospitalization for hypoglycemia
Временное ограничение: Baseline to 24 Months
|
Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms. |
Baseline to 24 Months
|
|
Initiation of Dialysis
Временное ограничение: Baseline to 24 Months
|
Percentage of non-dialysis participants initiating dialysis across treatment arms |
Baseline to 24 Months
|
|
Cardiovascular Composite
Временное ограничение: Baseline to 24 Months
|
Composite of hospitalization for acute myocardial infarction, stroke, amputation, or heart failure across treatment arms. |
Baseline to 24 Months
|
|
Kidney Transplantation
Временное ограничение: Baseline to 24 months
|
Percentage of participants receiving kidney transplantation across treatment arms. |
Baseline to 24 months
|
|
Healthcare utilization
Временное ограничение: 24 months
|
Health care utilization over 24 months including number of hospital admissions, emergency department, outpatient and primary care visits, specialist visits, rehabilitation, allied health care visits. Measured using provincial administrative health data. |
24 months
|
|
Health care costs
Временное ограничение: 24 months
|
Health care costs over 24 months, including total health care costs, hospitalization-related costs, emergency department costs, outpatient and physician costs, medication costs. Measured in Canadian dollars (CAD) using provincial administrative health data. |
24 months
|
Соавторы и исследователи
Спонсор
Спонсор
Следователи
Следователи
- Главный следователь: Kristin Clemens, MD, St. Joseph's Health Care London, Western University
- Главный следователь: Louise Moist, MD, London Health Sciences Centre
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Патологические процессы
- Расстройства питания
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Хроническое заболевание
- Атрибуты болезни
- Переедание
- Масса тела
- Почечная недостаточность
- Избыточный вес
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Ожирение
- Почечная недостаточность, хроническая
- полуглутид
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- PIVOT
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .