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

NCT06968728 | Not Yet Recruiting

• 1 other identifier: 2024-01997-01
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. Through this effort, the investigators hope to identify potential sleep-related biomarkers and behavioral targets for early intervention to support metabolic and cognitive health.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 years

Secondary Outcomes (13)

• Correlation Between 24-Hour Glycemic Variability and Brain Health

  4 years

• Correlation Between Sleep Patterns,Gut Microbiota Composition and Brain Health

  4 years

• Correlation Between 24-Hour Glycemic Variability and Gut Microbiota Composition

  4 years

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

  4 years

• Correlation Between Meal Timing,Sleep Health, and Glycemic Control

  4 years

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Uppsala University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood, fecal sample

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Christian Benedict, PhD

CONTACT

+46 18 471 43 30; christian.benedict@farmbio.uu.se

Bettina Sielaff, MD

CONTACT

+46 076-1411449; bettina.sielaff@regiondalarna.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2030
• Last Updated: May 18, 2025

Record last verified: 2025-05