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Insomnia and Insulin Resistance

Insomnia, Metabolic Syndrome and Insulin Resistance

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07333586
Enrollment
20
Registered
2026-01-12
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Insulin Resistance

Brief summary

Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. Chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States. The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. This study will explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.) and provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population. 20 subjects with insomnia will be recruited. They will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigator will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.

Detailed description

Insomnia symptoms are linked to metabolic syndrome (MetS), which includes abnormal glucose metabolism, insulin resistance (IR), and incidence of diabetes. In young healthy individuals, shortened sleep duration results in IR and elevated free fatty acid concentrations and has been associated with circadian misalignment. Additionally, individuals with type 2 diabetes (T2D) frequently have insufficient sleep or poor sleep quality, and greater sleep disturbances are associated with poorer glycemic control. Thus chronic sleep deficit is a major predictor of disease and early mortality. Further, insomnia is the most common sleep disorder in the United States, impacting at least 10% of the general population and \ 40% of those with T2D. Although stress or changes in lifestyle habits often cause short-term insomnia, chronic insomnia (Insomnia Disorder) is defined as difficulty falling or staying asleep that causes daytime impairment 3 or more nights a week, lasts 3 or more months, and cannot be fully explained by another health problem. The recommended first line of treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a multidimensional treatment that targets the thoughts and behaviors that perpetuate insomnia symptoms over time. The cognitive components of the therapy empower patients to challenge their automatic thoughts and reactions to poor sleep, and the behavioral components focus on matching time in bed to sleep ability in order to increase homeostatic sleep drive (or natural propensity for sleep). CBT-I improves insomnia in many populations (e.g., among those with psychological and physical comorbidities, chronic pain, etc). CBT-I has also demonstrated efficacy in reducing insomnia symptoms among those with IR in two pilot studies, but no studies have been powered to test CBT-I effects on metabolic outcomes within this population. Obesity is a leading risk factor for impaired metabolic health. Given the impact of insomnia symptoms on MetS, effective treatment of insomnia may improve metabolic outcomes among those with obesity. This study aims to: 1. Demonstrate the feasibility of the proposed CBT-I protocol. Specifically, the investigators hypothesize that ≥85% of participants will complete all assigned treatment sessions and follow-ups. 2. Replicate previous findings that CBT-I reduces insomnia among obese adults with insomnia. 3. Explore CBT-I effects on MetS outcomes (ie. blood pressure, triglycerides, etc.). 4. Provide preliminary evidence that CBT-I impacts IR and fasting glucose concentrations within this population. 20 subjects with insomnia will be recruited. Participants will be randomly assigned to either CBT-i or sleep hygiene. The intervention is 5 wks. Pre and post intervention, the investigators will have participants fill out a number of questionnaires, a daily sleep diary, 2 weeks of actigraphy measuring sleep and physical activity and there will be a single blood draw at the beginning and the end of the study.

Interventions

BEHAVIORALCBT-I

meets with "coach" who is teaching the participant how to deal with insomnia meets 5 times/once a week with the coach

BEHAVIORALsleep hygiene

meets with coach 1 time and is teaching the participant how to improve their sleep

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

ages 18-50 y BMI 28-45 kg/m2 Score on the Insomnia Severity Index ≥15.

Exclusion criteria

contraindications for CBT-I (mania or seizure disorder) symptoms requiring immediate attention (e.g., psychosis, suicide intent) report illicit substance use on a monthly basis (e.g., cocaine, opioids) receiving behavioral treatment for insomnia overt cardiovascular disease overt renal disease thyroid disease cancer pregnant dieting using GLP-1 agonists taking exogenous insulin

Design outcomes

Primary

MeasureTime frameDescription
insulin resistancebaseline and through study completion, an average of 9 weeksHOMA-IR calculation

Secondary

MeasureTime frameDescription
sleep durationbaseline and through study completion, an average of 9 weeksmeasuring sleep duration with Actigraph

Contacts

CONTACTMatt McDonald, MS
mjmdr4@missouri.edu5737722519
CONTACTJill Kanaley, PhD
kanaleyj@missouri.edu5737722519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026