Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial
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: StenoFood App.
- Кому может быть актуально
- Состояния в реестре: Diabetes Type 2, Kidney Disease. Базовые параметры: 18 лет — 74 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
- Дания
- 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
SBI 2024-2026 STENO FOOD CONCEPT
Обзор
This study evaluates whether a digital patient education program can improve adherence to KDIGO 2022 dietary recommendations (low sodium and optimal protein intake) among patients with type 2 diabetes and chronic kidney disease (eGFR 30-59 ml/min).
Подробное описание
The study investigates the effect of a newly developed digital education platform, the StenoFOOD app, which provides personalized dietary guidance for individuals with type 2 diabetes and reduced kidney function. Participants are followed for six months, during which changes in sodium and protein intake are assessed, together with blood pressure and several exploratory outcomes.
Participants are assigned to one of two groups. The intervention group is recruited from Steno Diabetes Center Copenhagen and receives the app-based educational program, which includes dietary guidance and self-monitoring tools. The control group is recruited from Nordsjællands Hospital and receives standard care in the diabetes outpatient clinic. The primary outcome is the change in sodium intake, estimated from 24-hour urinary sodium excretion. Secondary outcomes include changes in protein intake, while exploratory outcomes cover blood pressure, albuminuria, potassium and phosphate excretion, food literacy, digital health literacy, and patient-reported measures.
Eligibility requires a diagnosis of type 2 diabetes, age between 18 and 74 years, a BMI below 35, and moderately reduced kidney function. Participants must also have stable medical treatment for at least three months and be able to read and understand Danish. Exclusion criteria include other types of diabetes, active cancer, certain gastrointestinal conditions, a vegan diet, or the use of sodium chloride tablets. Access to the digital platform is required for those assigned to the intervention arm.
The study is conducted at Steno Diabetes Center Copenhagen in Herlev and at Nordsjællands Hospital in Hillerød. It is sponsored by Steno Diabetes Center Copenhagen with collaboration from Rigshospitalet and Nordsjællands Hospital. The study has been approved by the Regional Ethics Committee in the Capital Region of Denmark.A total of 104 participants are expected to be enrolled.
Вмешательства
- Устройство StenoFood App
Digital patient education program (app-based) with dietary guidance and self-monitoring tools
Первичные конечные точки
- Change in sodium excretion between measurements at baseline and 6 months follow-up [Срок оценки: 6 month]
Вторичные конечные точки (4)
- Change in protein intake (g/kg/day) between baseline and follow-up measurements [Срок оценки: 6 months]
- Change in Blood pressure between baseline and follow-up [Срок оценки: 6 months]
- Change in albumin, potassium and phosphate excretion between baseline and follow-up [Срок оценки: 6 month]
- Change in dietary patterns between baseline and follow-up [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Type 2 diabetes (ICD-10 DE11.x)
- Age 18-74 years
- BMI < 35 kg/m²
- eGFR 30-59 ml/min and UACR > 30 mg/g
- Stable medication for ≥3 months
- Ability to read and understand Danish
Критерии исключения
- Type 1 diabetes or other diabetes types
- Current vegan diet
- Active cancer
- Short bowel syndrome or celiac disease
- Use of sodium chloride tablets
- No access to digital platform (intervention group only)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Дания · 2 центра
- Steno Diabetes Center Copenhagen, — Herlev
- Nordsjællands Hospital, Hillerød — Hillerød
Публикации
- Alhashimi L, Cordwin DJ, Dandu C, Hummel SL, Dorsch MP. Patient self-assessment of urine dipsticks to estimate sodium intake in patients with hypertension. Clin Nutr ESPEN. 2022 Oct;51:295-300. doi: 10.1016/j.clnesp.2022.08.011. Epub 2022 Aug 12. PMID 36184219
Идентификаторы
NCT: NCT07485075 · Steno Food Concept, H-25033125