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NCT Number: NCT06624046

Circadian Mechanisms, Glucose, and CV Risks in T1D

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Pamela Martyn-Nemeth, PhD

CONTACT

[email protected]

312-996-7903

Pamela Martyn-Nemeth, PhD

PRINCIPAL_INVESTIGATOR

Sirimon Reutrakul, MD

CONTACT

[email protected]

312-413-3631

Sirimon Reutrakul, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep stability intervention

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.

Primary outcomes

  1. Glycemic status

    Time frame: From enrollment to week 12

    Continuous glucose monitor (CGM)

  2. Glycemic control

    Time frame: From enrollment to week 12

    Hemoglobin A1C

  3. Insulin sensitivity

    Time frame: From enrollment to week 12

    Insulin sensitivity

Secondary outcomes

  1. Circadian regulation DLMO

    Time frame: enrollment to week 12

    dim-light melatonin onset (DLMO)

  2. Circadian regulation Melatonin

    Time frame: Enrollment to week 12

    Melatonin metabolite amplitude

  3. Circadian regulation actigraphy

    Time frame: enrollment to week 12

    actigraphy-derived rest activity rhythm

  4. Circadian regulation CLOCK gene

    Time frame: enrollment to week 12

    endothelial cell CLOCK gene mRNA expression

  5. Circadian regulation light

    Time frame: enrollment to week 12

    light exposure

  6. Circadian regulation meals

    Time frame: enrollment to week 12

    Meal timing

  7. Cardiovascular outcome blood pressure

    Time frame: enrollment to week 12

    24 hour blood pressure

  8. Cardiovascular outcome endothelial function

    Time frame: enrollment to week 12

    endothelial flow-mediated dilation

  9. Cardiovascular outcome arterial stiffness

    Time frame: enrollment to week 12

    pulse wave velocity

  10. Cardiovascular outcome echocardiogram

    Time frame: enrollment to week 12

    echocardiogram

  11. Cardiovascular outcome CIMT

    Time frame: enrollment to week 12

    carotid intima lining thickness (CIMT)

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela Martyn-Nemeth, PhD

CONTACT

[email protected]

312-996-7903

Sirimon Reutrakul, MD

CONTACT

[email protected]

312-996-6060

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 2, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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