Obesity and OverweightNNFNCT06968728
Sleep, Glucose, and Brain Health in Obesity and Overweight Individuals
An observational study of Obesity and Overweight and Type 2 Diabetes, run by Uppsala University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Obesity and Overweight, Type 2 Diabetes, Sleep
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 15 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include participants across a range of body weight categories, specifically normal weight, overweight, and obese individuals.
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Interplay Between Sleep Disturbances, Glucose Regulation, and Brain Health in Individuals With Overweight and Obesity
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.
Read the detailed description
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.
- Conditions
- Obesity and Overweight, Type 2 Diabetes, Sleep, Brain Health
- Keywords
- obesity, overweight, type 2 diabetes, glucose control, brain health, diet, sleep disruption, gut microbiota
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
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.
Measured: 4 years
Secondary outcomes (13)
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.
Measured: 4 years
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.
Measured: 4 years
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.
Measured: 4 years
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.
Measured: 4 years
Correlation Between Meal Timing,Sleep Health, and Glycemic Control
This aim will assess whether regularity in meal timing is associated with sleep health status, including sleep duration, efficiency, and consistency, especially the timing of the last meal before sleep and its association with sleep health. In addition, we will examine how eating patterns and food types influence glycemic variability.
Measured: 4 years
Correlation Between Sleep Health and Mood
This aim will assess whether poorer sleep health is associated with more negative affect and less positive affect, as measured by the Positive and Negative Affect Schedule (PANAS), increased depressive symptoms as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS), and lower scores on an app-based mood scale.
Measured: 4 years
Correlation Between 24-Hour Glycemic Variability and Mood
This aim will assess whether increased 24-hour glycemic variability is associated with more negative affect and less positive affect, as measured by the Positive and Negative Affect Schedule (PANAS), increased depressive symptoms as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS), and lower scores on an app-based mood scale administered daily.
Measured: 4 years
Quantification of circulating cancer-related biomarkers via Olink Flex Panel
This aim will assess the potential association between selected blood-based biomarkers, implicated in the pathogenesis of colorectal, breast, prostate, and lung cancer, and glycemic control (measured by continuous glucose monitoring), brain health (assessed via neurodegenerative biomarkers, MRI, and verbal fluency), and sleep patterns. Up to 30 biomarkers will be quantified using the Olink Flex panel with absolute concentration assays (pg/mL), enabling targeted evaluation of cancer-related molecular signatures
Measured: 4 years
Broad proteomic profiling using Olink Reveal Panel
This aim will investigate whether glycemic control (measured by continuous glucose monitoring), brain health (assessed via neurodegenerative biomarkers, MRI, and verbal fluency), and sleep patterns are associated with protein profiles measured using the Olink Reveal panel, an exploratory platform targeting proteins involved in metabolic, immunologic, and neurodegenerative processes.
Measured: 4 years
Disease prediction by quantification of exosomes
Determine if glycemic control (measured by continuous glucose monitoring), brain health (assessed via neurodegenerative biomarkers, MRI, and verbal fluency), and sleep patterns are associated with specific exosome signatures.
Measured: 4 years
Physical Activity Measured by Fitbit and Its Associations with Glycemic Control and Brain Health
This aim will evaluate how physical activity levels, measured via Fitbit, are associated with glycemic control (measured by CGM), brain health (neurodegenerative biomarkers, MRI, and verbal fluency), and sleep patterns.
Measured: 4 years
Association Between Screen Time Patterns and Health Outcomes: Investigating Links with Glycemic Control, Brain Health, and Sleep Patterns
To investigate whether weekly screen time, as well as screen use prior to and during bedtime, are associated with glycemic control (measured by CGM), brain health (neurodegenerative biomarkers, MRI, and verbal fluency), and sleep patterns.
Measured: 4 years
15. Association Between Subjective Sleep Health and 24-Hour Glycemic Variability and Brain Health
This aim will assess whether subjective sleep health-measured using the Insomnia Severity Index (ISI), a widely used questionnaire for evaluating insomnia severity, and the Pittsburgh Sleep Quality Index (PSQI)-is associated with glycemic control (measured by continuous glucose monitoring), brain health (neurodegenerative biomarkers, MRI, and verbal fluency), and objective sleep patterns.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Benedict, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968728
- Sponsor's protocol ID
- 2024-01997-01
- Acronym
- NNF
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interplay Between Sleep Disturbances, Glucose Regulation, and Brain Health in Individuals With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06968728
- Acronym / sponsor ID
- NNF / 2024-01997-01
- Conditions
- Obesity and Overweight, Type 2 Diabetes, Sleep, Brain Health
- Keywords
- obesity, overweight, type 2 diabetes, glucose control, brain health, diet, sleep disruption, gut microbiota
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include participants across a range of body weight categories, specifically normal weight, overweight, and obese individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between objective sleep health status and 24-hour glycemic variability
Time frame: 4 years
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.
Correlation Between Sleep Patterns and Brain Health
Time frame: 4 years
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.
13 secondary outcomes
Correlation Between 24-Hour Glycemic Variability and Brain Health
Time frame: 4 years
Correlation Between Sleep Patterns,Gut Microbiota Composition and Brain Health
Time frame: 4 years
Correlation Between 24-Hour Glycemic Variability and Gut Microbiota Composition
Time frame: 4 years
Correlation Between Sleep Patterns, Adiposity, Food Choices, and Blood Levels of Appetite-Regulating Hormones
Time frame: 4 years
Correlation Between Meal Timing,Sleep Health, and Glycemic Control
Time frame: 4 years
Correlation Between Sleep Health and Mood
Time frame: 4 years
Correlation Between 24-Hour Glycemic Variability and Mood
Time frame: 4 years
Quantification of circulating cancer-related biomarkers via Olink Flex Panel
Time frame: 4 years
Broad proteomic profiling using Olink Reveal Panel
Time frame: 4 years
Disease prediction by quantification of exosomes
Time frame: 4 years
Physical Activity Measured by Fitbit and Its Associations with Glycemic Control and Brain Health
Time frame: 4 years
Association Between Screen Time Patterns and Health Outcomes: Investigating Links with Glycemic Control, Brain Health, and Sleep Patterns
Time frame: 4 years
15. Association Between Subjective Sleep Health and 24-Hour Glycemic Variability and Brain Health
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight and Type 2 Diabetes, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Benedict, PhD (+46 18 471 43 30, christian.benedict@farmbio.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between objective sleep health status and 24-hour glycemic variability (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.