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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-65
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

The study will include participants across a range of body weight categories, specifically normal weight, overweight, and obese individuals.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Correlation between objective sleep health status and 24-hour glycemic variability

An assessment will be made to determine whether poorer sleep health-measured using wearable-derived metrics such as sleep duration, sleep efficiency, sleep regularity, and the apnea-hypopnea index-is associated with a greater proportion of time spent outside the recommended glucose range of 70 to 180 mg/dL and with increased glucose variability, as indicated by the coefficient of variation. Additionally, we will evaluate which specific sleep metrics, including total sleep duration, sleep efficiency, sleep onset timing, sleep regularity, and the presence of sleep-disordered breathing, show the strongest associations with glycemic outcomes.

Time frame
4 years
2

Correlation Between Sleep Patterns and Brain Health

Assessment of whether poorer sleep health is associated with elevated concentrations of brain health biomarkers, including tau and neurofilament light chain (NfL), poorer performance on a verbal fluency task, and variations in total and regional gray matter volume.

Time frame
4 years

Secondary outcomes

1

Correlation Between 24-Hour Glycemic Variability and Brain Health

This aim will assess whether increased 24-hour glycemic variability is associated with elevated concentrations of brain health biomarkers, including tau and neurofilament light chain (NfL), as well as variations in cognitive performance and brain structure, such as gray matter volume.

Time frame
4 years
2

Correlation Between Sleep Patterns,Gut Microbiota Composition and Brain Health

This aim will assess whether variations in sleep patterns, including sleep duration, efficiency, and regularity, are associated with differences in gut microbiota composition and diversity. In this context, we will also quantify fecal calprotectin concentrations to assess the presence of subclinical gut inflammation. And explore whether sleep-related changes in the gut microbiome are linked to brain health indicators such as neurodegenerative biomarkers and cognitive performance.

Time frame
4 years
3

Correlation Between 24-Hour Glycemic Variability and Gut Microbiota Composition

This aim will assess whether increased 24-hour glycemic variability is associated with changes in gut microbiota composition and diversity. In this context, we will also quantify fecal calprotectin concentrations to assess the presence of subclinical gut inflammation.

Time frame
4 years
4

Correlation Between Sleep Patterns, Adiposity, Food Choices, and Blood Levels of Appetite-Regulating Hormones

This aim will assess how variations in sleep patterns are associated with adiposity (body fat, waist circumference), food choices (derived from Food Frequency Questionnaire), and blood levels of appetite-regulating hormones, such as leptin, ghrelin, and adiponectin.

Time frame
4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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