Circadian Mechanisms, Glucose, and CV Risks in T1D

NCT ID: NCT06624046

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2029-08-31

Brief Summary

People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.

Detailed Description

People with type 1 diabetes (T1D) are disproportionately affected by cardiovascular disease (CVD). CVD is a leading cause of death in T1D, contributing to 40% of mortality. Sleep is recognized by both the American Heart Association and the American Diabetes Association as a critical health behavior to maintain glycemic control and reduce CVD risk. Short and/or irregular sleep have been associated with reduced glycemic control and non-dipping blood pressure in T1D, both of which are predictors of CV events. Emerging data suggest that behavioral sleep interventions targeting short or irregular sleep led to improved glycemic parameters. However, little is known about the mechanism by which improving sleep duration and/or regularity improves glycemic control and reduces CV risk in T1D. The investigators and others have shown that people with T1D often experience poor sleep health, including inadequate sleep duration, sleep irregularity, and poor sleep quality. The goals of this study are to examine the mechanisms by which improving sleep regularity through behavioral sleep intervention affects glycemic control and CVD risks in T1D adults. The investigators propose to extend our previous research by conducting a mechanistic study using a sleep stability manipulation. The investigators hypothesize that sleep stability impacts glycemic control and CV outcomes by improving circadian regulation. The investigators will conduct a 4-week behavioral sleep stability intervention in 100 T1D adults with irregular sleep, utilizing a sleep pre/post design. Circadian regulation will be assessed by dim-light melatonin onset (DLMO), melatonin metabolite amplitude (overnight urinary 6-sulfatoxymelatonin levels), actigraphy-derived rest-activity rhythm, endothelial cell CLOCK gene mRNA expression, and known zeitgebers of the central and peripheral circadian clocks (light exposure, meal timing). Main glycemic outcomes will be assessed by CGM, A1C, and assessment of insulin sensitivity. Main CV outcomes will include 24h blood pressure and endothelial FMD and other secondary vascular measures (pulse wave velocity, carotid intima media thickness, and echocardiographic parameters). Sleep will be objectively recorded. All parameters will be measured at baseline and end of intervention. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.

Conditions

Type 1 Diabetes (T1D)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single arm

Sleep stability intervention

Group Type: OTHER

Sleep stability intervention

Intervention Type: BEHAVIORAL

The sleep stability intervention will consist of three theory-based intervention components our team has developed and used in prior interventions: 1) self-monitoring using a wearable sleep tracker (Fitbit). This is well-liked by participants and increases awareness of their sleep goals. 2) Accountability coaching via weekly check-ins and daily monitoring of participants' wearable sleep tracking data and a coaching protocol.

Interventions

Sleep stability intervention

The sleep stability intervention will consist of three theory-based intervention components our team has developed and used in prior interventions: 1) self-monitoring using a wearable sleep tracker (Fitbit). This is well-liked by participants and increases awareness of their sleep goals. 2) Accountability coaching via weekly check-ins and daily monitoring of participants' wearable sleep tracking data and a coaching protocol.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults 18-50 years with a clinical diagnosis of T1D for at least one year
• Report habitual sleep irregularity ≥1 hour/week
• Desire to improve sleep, and own a smartphone (Android or iPhone)

Exclusion Criteria

• Self-reported A1C within the past 6 months ≥10%
• insomnia symptoms defined as Insomnia Severity Index score ≥15
• history of restless leg syndrome
• history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months
• rotating shift or night work or routinely sleeping after 3 AM.
• use of sleep medications/aids, significant medical comorbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, on renal replacement therapy [dialysis])
• depression (Patient Health Questionnaire 8 [PHQ-8] score ≥15)
• history of stroke with neurological deficits
• pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding.
• Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Pamela Martyn-Nemeth

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela Martyn-Nemeth, PhD

Role: CONTACT

pmartyn@uic.edu

312-996-7903

Sirimon Reutrakul, MD

Role: CONTACT

sreutrak@uic.edu

312-996-6060

Facility Contacts

Pamela Martyn-Nemeth, PhD

Role: primary

pmartyn@uic.edu

312-996-7903

Sirimon Reutrakul, MD

Role: backup

sreutrak@uic.edu

312-413-3631

Other Identifiers

R01HL174738

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0886

Identifier Type: -

Identifier Source: org_study_id