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NCT Number: NCT06848647

Treatment of Sleep Apnea to Improve Metabolic Health

Diabetes and prediabetes prevail among obstructive sleep apnea (OSA) patients. OSA and short sleep both detrimentally affect glycemic control regardless of obesity. With 1 in 10 adults having diabetes, 1 in 10 with prediabetes, and an estimated 600,000 affected by OSA in Sweden, attaining glycemic control is crucial. Though continuous positive airway pressure (CPAP) is the most effective treatment for OSA, its application lacks personalization, ignoring factors like comorbidities and sleep duration. Key unanswered questions regarding CPAP's impact on glycemic control include: 1) Does high CPAP adherence optimize glycemic control? 2) Should short sleep be addressed alongside OSA treatment for glycemic control? 3) Does long-term diabetes hinder CPAP's glycemic control efficacy? The purpose of this project is to enable precision health in CPAP treatment and producing a personalized treatment model for achieving glycemic control in patients with OSA, treated with CPAP. Taking advantage of a large unique patient cohort (600 patients followed over 18 months) with extensive and objective measures on CPAP adherence, OSA reduction, sleep duration, as well as information on comorbidities, anthropometric, lifestyle data, and a wide range of biomarkers related to glycemic control. This comprehensive approach and in-depth analysis will address these questions and generate a personalized treatment strategy for glycemic control in CPAP-treated OSA patients.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea CPAP Dyssomnias Metabolism Nervous System Diseases Patients Above 18 Years Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, Uppsala County, Sweden

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with obstructive sleep apnea
  • Planned for CPAP treatment
  • 18 years and above

Exclusion criteria

  • Patient not wanting to participate in study
  • Non-Swedish speaking
  • Judged by physician as non-fit for study participation

Treatment and study plan

Primary outcomes

  1. Homeostatic model assessment for insulin resistance (HOMA-IR)

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical marker: HOMA-IR calculated from blood glucose and serum insuling

  2. Glycated hemoglobin (HbA1c)

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical maker: glycated hemoglobin (HbA1c) in % and mmol/mol

  3. Blood glucose

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical marker: blood glucose in mmol/L

  4. Serum insulin

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical marker: serum insulin in mU/L

  5. Plasma triglycerides

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical marker: Triglycerides in mg/dL

  6. Plasma cholesterol

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical marker: plasma cholesterol in mg/dL

  7. HDL-cholesterol

    Time frame: From enrollment to the end of treatment at 12 months

    Clinial marker: high-density lipoprotein (HDL) cholesterol in mg/dL

  8. LDL-cholesterol

    Time frame: From enrollment to the end of treatment at 12 months

    Clinical marker: low-density lipoprotein (LDL) cholesterol in mg/dL

Study contacts

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

Jenny Theorell-Haglow, A.Prof, PhD

CONTACT

[email protected]

+46 18 6110242

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Official study title

Treatment of Sleep Apnea to Improve Metabolic Health - a Novel Approach to Unanswered Questions

Acronym: GLYCOSACT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

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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