Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sleep Apnea - Obstructive
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 35 years and 65 years
- Gender
- Both males and females
Description
Positive airway pressure (PAP) is standard therapy for OSA, but has shown mixed results for improvement of insulin sensitivity, and does not reduce CV events and mortality, even in patients with established CV disease. Hence, eliminating IH alone with standard PAP therapy may not be sufficient to re...
Positive airway pressure (PAP) is standard therapy for OSA, but has shown mixed results for improvement of insulin sensitivity, and does not reduce CV events and mortality, even in patients with established CV disease. Hence, eliminating IH alone with standard PAP therapy may not be sufficient to restore metabolism. Additional adjunct strategies (such as metformin) known to improve metabolism may be required to reduce metabolic burden and CV risk in OSA patients. The aim of this study is to examine the longitudinal changes in metabolism of OSA patients receiving both PAP and metformin treatment. The MET-OSA study will last about 4 months. After screening the participants to determine eligibility, baseline study measures will be obtained and the participants will be provided with standard PAP for OSA treatment. Participants will also be randomized to receive either placebo or metformin treatment for 3 months. Compliance to study drug will be determined during monthly follow-up visits. Final study visit will include assessment of all baseline study measures.
Tracking Information
- NCT #
- NCT04530747
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Principal Investigator: Prachi Singh, PhD Pennington Biomedical Research Center