Меню
Набор скоро начнётся NCT06968728

Sleep, Glucose, and Brain Health in Obesity and Overweight Individuals

Наблюдательное Obesity and Overweight Type 2 Diabetes Sleep Brain 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obesity and Overweight, Type 2 Diabetes, Sleep, Brain Health. Базовые параметры: 40 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Interplay Between Sleep Disturbances, Glucose Regulation, and Brain Health in Individuals With Overweight and Obesity

Обзор

The primary aim of the NNF study is to investigate both cross-sectional and longitudinal associations between sleep patterns-measured over two consecutive weeks at baseline and again one year later-and indicators of glycemic control and brain health in a cohort of middle-aged adults. Through this effort, the investigators hope to identify potential sleep-related biomarkers and behavioral targets for early intervention to support metabolic and cognitive health.

Подробное описание

This study investigates the relationship between sleep patterns, glycemic control, and brain health in adults, with a particular focus on middle-aged individuals, including those with normal weight as well as those with overweight or obesity-the latter representing a demographic at elevated risk for type 2 diabetes (T2D). Individual sleep exposures such as sleep duration, sleep quality, sleep timing, and sleep regularity have all been associated with impaired glucose metabolism and indicators of compromised brain health. However, well-controlled studies that comprehensively examine how overall sleep health-considering all these dimensions-is related to both glycemic control and brain health remain limited.

To address this research aim, participants will be recruited from two Swedish sites: Dalarna and Uppsala. Following enrollment and an on-site baseline assessment session, participants' lifestyle behaviors will be monitored over 14 consecutive days. Specifically, nighttime sleep will be assessed using a wearable, FDA-cleared sleep device (SleepImage); 24-hour interstitial glucose levels will be tracked via a continuous glucose monitor (CGM); and physical activity will be recorded using a wrist-worn activity tracker (Fitbit). During this monitoring period, participants will also log their dietary intake and mood through smartphone-based assessments. After the 14-day monitoring period, participants will return for a concluding on-site session.

During the on-site sessions or the 14-day monitoring period, biological samples will be collected to assess metabolic, hormonal, inflammatory, and neurodegenerative biomarkers. Blood samples will be analyzed for markers such as sex hormones, HbA1c, C-reactive protein (CRP), leptin, ghrelin, adiponectin, and brain health indicators including brain-derived tau and neurofilament light chain (NfL), in addition to broader proteomic and metabolomic profiles. Stool samples will also be collected for further analyses. In addition to providing biological samples, all participants-provided they meet inclusion criteria and give informed consent-will undergo structural brain imaging using magnetic resonance imaging (MRI). Cognitive assessments will include verbal fluency tasks and validated psychological instruments to evaluate mood and cognitive function.

The entire protocol will be repeated after one year, allowing for the assessment of longitudinal changes in sleep patterns, metabolic health, and brain function over time.

The primary aim of the NNF study is to investigate both cross-sectional and longitudinal associations between sleep patterns-measured over two consecutive weeks at baseline and again one year later-and indicators of glycemic control and brain health in a cohort of middle-aged adults. Secondary aims include, for example, exploring how sleep patterns relate to variability in protein and metabolite abundances in blood, among other metabolic, cognitive, and biological outcomes detailed below.

Первичные конечные точки

  • Correlation between objective sleep health status and 24-hour glycemic variability [Срок оценки: 4 years]
  • Correlation Between Sleep Patterns and Brain Health [Срок оценки: 4 years]
Вторичные конечные точки (12)
  • Correlation Between 24-Hour Glycemic Variability and Brain Health [Срок оценки: 4 years]
  • Correlation Between Sleep Patterns,Gut Microbiota Composition and Brain Health [Срок оценки: 4 years]
  • Correlation Between 24-Hour Glycemic Variability and Gut Microbiota Composition [Срок оценки: 4 years]
  • Correlation Between Sleep Patterns, Adiposity, Food Choices, and Blood Levels of Appetite-Regulating Hormones [Срок оценки: 4 years]
  • Correlation Between Meal Timing,Sleep Health, and Glycemic Control [Срок оценки: 4 years]
  • Correlation Between Sleep Health and Mood [Срок оценки: 4 years]
  • Correlation Between 24-Hour Glycemic Variability and Mood [Срок оценки: 4 years]
  • Quantification of circulating cancer-related biomarkers via Olink Flex Panel [Срок оценки: 4 years]
  • Broad proteomic profiling using Olink Reveal Panel [Срок оценки: 4 years]
  • Disease prediction by quantification of exosomes [Срок оценки: 4 years]
  • Physical Activity Measured by Fitbit and Its Associations with Glycemic Control and Brain Health [Срок оценки: 4 years]
  • Association Between Screen Time Patterns and Health Outcomes: Investigating Links with Glycemic Control, Brain Health, and Sleep Patterns [Срок оценки: 4 years]

Критерии участия

  • Be between 40 and 65 years of age
  • Be classified as having normal weight, overweight, or obesity
  • Not be pregnant
  • Not be currently using glucose-lowering medications or undergoing glucose therapy
  • Not have a diagnosis of type 1 or type 2 diabetes mellitus
  • Not have kidney disease, thyroid disorders, or inflammatory bowel disease
  • Not have undergone bariatric surgery
  • Not actively participating in a weight-loss diet
  • Not using medications that affect glucose levels or taking sleep-inducing pills
  • Not working night shifts
  • Not have traveled across time zones in the past 3 months
  • Not have any severe chronic medical illnesses or severe psychiatric disorders
  • Be able and willing to wear all required study monitoring devices
  • Own a smartphone with Bluetooth capability

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06968728 · 2024-01997-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗