NNFSleep, Glucose Regulation, and Brain Health in Overweight and Obesity
Data Collection
Collected from today forward - ProspectiveBody Weight+10
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 15, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding how sleep habits affect blood sugar control and brain health, particularly in middle-aged adults who are overweight or obese. These groups are at higher risk for developing type 2 diabetes, making it essential to understand how factors like sleep duration, quality, and timing might impact their health. The study aims to fill a gap in research by exploring how overall sleep health relates to both blood sugar levels and brain function, which could lead to better health strategies for preventing diabetes and maintaining brain health. Participants will be recruited from two locations in Sweden and will have their sleep patterns monitored using a special sleep device for 14 days. Their glucose levels will be checked continuously with a small monitor, and their physical activity will be tracked with a wristband. Participants will also log their food intake and mood through a smartphone app. During this period, blood and stool samples will be collected to analyze various health markers. Additionally, participants will undergo brain scans and perform tests to assess their cognitive abilities. This comprehensive study will be repeated after a year to observe any changes over time, providing valuable insights into the long-term impacts of sleep on health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives