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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究連絡先
研究連絡先
- 名前：Heather LaPier
- 電話番号：65373 519-646-6100
- メール：heather.lapier@sjhc.london.on.ca
研究場所
-
-
Ontario
-
London、Ontario、カナダ
- London Health Sciences Centre
-
コンタクト：
- Heather LaPier, MD
- 電話番号：65373 519-646-6100
- メール：heather.lapier@sjhc.london.on.ca
-
London、Ontario、カナダ、N6A4V2
- St. Joseph's Health Care
-
コンタクト：
- Heather LaPier
- 電話番号：65373 519-646-6100
- メール：heather.lapier@sjhc.london.on.ca
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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.
他の名前：
|
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Weight
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
時間枠：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
時間枠：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)
時間枠：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.
時間枠：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%
時間枠：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%
時間枠：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%
時間枠：26 weeks +/- 14 days
|
Percentage of participants achieving at least 15% reduction in body weight from baseline. |
26 weeks +/- 14 days
|
|
Weight Loss ≥20%
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：Baseline to 26 weeks +/- 14 days
|
Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation |
Baseline to 26 weeks +/- 14 days
|
|
Acute Biliary Disease
時間枠：Baseline to 26 weeks +/- 14 days
|
Incidence of acute biliary disease. |
Baseline to 26 weeks +/- 14 days
|
|
Acute Pancreatitis
時間枠：Baseline to 26 weeks +/- 14 days
|
Incidence of acute pancreatitis. |
Baseline to 26 weeks +/- 14 days
|
|
Diabetic Retinopathy Interventions
時間枠：Baseline to 26 weeks +/- 14 days
|
Incidence of interventions for diabetic retinopathy |
Baseline to 26 weeks +/- 14 days
|
|
Injection-site reactions
時間枠：Baseline to 26 weeks +/- 14 days
|
Incidence of injection-site reactions in the intervention arm. |
Baseline to 26 weeks +/- 14 days
|
|
Malignant Neoplasms
時間枠：Baseline to 26 weeks +/- 14 days
|
Incidence of malignant neoplasms. |
Baseline to 26 weeks +/- 14 days
|
|
Coaching Visit Adherence
時間枠：Baseline to 26 weeks +/- 14 days
|
Percentage of participants completing ≥4 of 6 coaching visits. |
Baseline to 26 weeks +/- 14 days
|
|
Semaglutide Discontinuation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in HbA1c
時間枠：Baseline to 24 Months
|
Change in glycated hemoglobin among participants with diabetes across treatment arms. |
Baseline to 24 Months
|
|
Hospitalization for Hyperglycemia
時間枠：Baseline to 24 Months
|
Incidence of hospitalization for hyperglycemia in participants with diabetes across treatment arms |
Baseline to 24 Months
|
|
Hospitalization for hypoglycemia
時間枠：Baseline to 24 Months
|
Incidence of hospitalization for hypoglycemia in participants with diabetes across treatment arms. |
Baseline to 24 Months
|
|
Initiation of Dialysis
時間枠：Baseline to 24 Months
|
Percentage of non-dialysis participants initiating dialysis across treatment arms |
Baseline to 24 Months
|
|
Cardiovascular Composite
時間枠：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
時間枠：Baseline to 24 months
|
Percentage of participants receiving kidney transplantation across treatment arms. |
Baseline to 24 months
|
|
Healthcare utilization
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Kristin Clemens, MD、St. Joseph's Health Care London, Western University
- 主任研究者：Louise Moist, MD、London Health Sciences Centre
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- PIVOT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。