Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see if metformin improves metabolism in patients with obstructive sleep apnea (OSA) using positive airway pressure (PAP) therapy. Metformin is approved by the Food and Drug Administration (FDA) for the treatment and prevention of diabetes. It is not approved for use in patients with OSA.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pennington Biomedical Research Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Body mass index (BMI) ≥ 30-50 kg/m2 (inclusive).

• Apnea-Hypopnea Index ≥ 15 events/h.

• Must be able to provide written informed consent.

• Willing to participate and adhere to study procedures (video recorded in-lab sleep studies, PAP treatment, take study drug, have adipose tissue and skeletal muscle biopsies).

• Women of child-bearing potential must agree to use appropriate contraception to avoid pregnancy throughout the study.

• Willing to have blood, as well as adipose and muscle tissue stored for future use.

Exclusion Criteria:

• HbA1c > 6.4%.

• Severe or uncontrolled hypertension defined as systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg on the average of three seated measurements after being at rest for at least 5 minutes.

• Significant cardiovascular, hepatic, renal, neurologic, or psychiatric disease as determined by the study physician.

• Pregnancy, breast feeding or planning pregnancy in the coming 4 months.

• Impaired renal function defined as eGFR <60ml/min/1.73m2 (estimated with CKD-EPI method).

• Known hypersensitivity to metformin.

• Currently taking a glucose lowering or weight loss medications.

• Current PAP use or use of PAP in the past 6 months.

• Currently taking antihypertensive and lipid-lowering medications known to affect adipose tissue and skeletal muscle metabolism. For example, statins and drugs targeting renin-angiotensin system will not be allowed. However, use of diuretics, beta-blockers, alpha-blockers and calcium channel blockers may be allowed provided the participant is on a stable dose for at least 3 months prior to the study visit.

• Oxygen desaturation index <15 events/h of sleep.

• Any medication or condition that, in the opinion of the medical investigator, could interfere with the study outcomes or put the subject at risk by participating in the study.