Circadian Mechanisms, Glucose, and CV Risks in T1D

June 25, 2026 updated by: Pamela Martyn-Nemeth, University of Illinois at Chicago

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Pamela Martyn-Nemeth, PhD
  • Phone Number: 312-996-7903
  • Email: pmartyn@uic.edu

Study Contact Backup

  • Name: Sirimon Reutrakul, MD
  • Phone Number: 312-996-6060
  • Email: sreutrak@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago
        • Contact:
          • Pamela Martyn-Nemeth, PhD
          • Phone Number: 312-996-7903
          • Email: pmartyn@uic.edu
        • Contact:
        • Principal Investigator:
          • Pamela Martyn-Nemeth, PhD
        • Principal Investigator:
          • Sirimon Reutrakul, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm
Sleep stability intervention
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic status
Time Frame: From enrollment to week 12
Continuous glucose monitor (CGM)
From enrollment to week 12
Insulin sensitivity
Time Frame: From enrollment to week 12
Insulin sensitivity
From enrollment to week 12
Glycemic control
Time Frame: From enrollment to week 12
Hemoglobin A1C
From enrollment to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Circadian regulation DLMO
Time Frame: enrollment to week 12
dim-light melatonin onset (DLMO)
enrollment to week 12
Circadian regulation Melatonin
Time Frame: Enrollment to week 12
Melatonin metabolite amplitude
Enrollment to week 12
Circadian regulation actigraphy
Time Frame: enrollment to week 12
actigraphy-derived rest activity rhythm
enrollment to week 12
Circadian regulation CLOCK gene
Time Frame: enrollment to week 12
endothelial cell CLOCK gene mRNA expression
enrollment to week 12
Circadian regulation light
Time Frame: enrollment to week 12
light exposure
enrollment to week 12
Circadian regulation meals
Time Frame: enrollment to week 12
Meal timing
enrollment to week 12
Cardiovascular outcome blood pressure
Time Frame: enrollment to week 12
24 hour blood pressure
enrollment to week 12
Cardiovascular outcome endothelial function
Time Frame: enrollment to week 12
endothelial flow-mediated dilation
enrollment to week 12
Cardiovascular outcome arterial stiffness
Time Frame: enrollment to week 12
pulse wave velocity
enrollment to week 12
Cardiovascular outcome echocardiogram
Time Frame: enrollment to week 12
echocardiogram
enrollment to week 12
Cardiovascular outcome CIMT
Time Frame: enrollment to week 12
carotid intima lining thickness (CIMT)
enrollment to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-0886
  • R01HL174738 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data identified for sharing will be processed and shared in the UIC institutional repository, INDIGO. Data to be generated include:

  1. Biochemical data
  2. Body composition
  3. Vascular and cardiac measures
  4. Fat biopsies to measure circadian CLOCK gene and mRNA expression.
  5. Objective sleep and physical activity
  6. Demographic and questionnaire data
  7. Meal timing, diet composition, and total daily calorie intake will be obtained using a 7-day dietary log (ASA-24).

De-identified data noted above will be shared except raw questionnaire data and mp4 vascular and cardiac video recordings

IPD Sharing Time Frame

Scientific data will be shared as soon as possible, and no later than the time of publication, or the end of the award period, whichever comes first. Deidentified data will be available in INDIGO in perpetuity and with open access to the scientific community.

IPD Sharing Access Criteria

The UIC institutional repository provides shared datasets and metadata only records with a persistent identifier DOI, allowing for discovery and attribution. The ClinicalTrials.gov database additionally provides unique identifiers for submitted studies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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