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RECRUITING Not applicable ClinicalTrials.gov

Insomnia and Insulin Resistance

Sponsor: University of Missouri-Columbia • ClinicalTrials.gov ID: NCT07333586

Registry updated: 2026-09-24
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Description

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.

Interventions

  • CBT-I (Behavioral)
    meets with "coach" who is teaching the participant how to deal with insomnia meets 5 times/once a week with the coach
  • sleep hygiene (Behavioral)
    meets with coach 1 time and is teaching the participant how to improve their sleep

Eligibility criteria

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

Conditions

Insomnia Insulin Resistance

Locations

  • University of Missouri — Columbia, Missouri, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record