Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.

• Status: Terminated
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension and nightly melatonin supplementation in the community is a feasible intervention with a beneficial effect on the following chronic kidney disease (CKD) risk factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by 24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance and β-cell response to a mixed meal protocol.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) ≥ 30 kg/m2

• Hemoglobin A1c (HbA1c) 6.7-6.4%

• Self reported sleep < 7 hours per night

Exclusion Criteria:

• Inability to extend sleep by one hour each night

• Current or prior history of diabetes OR random serum glucose ≥200mg/dL

• Pregnancy

• Preexisting lung disease requiring oxygen

• Preexisting cardiovascular disease

• Active or uncontrolled psychotic disorder

• Active or uncontrolled bipolar illness

• Active malignancy with in the prior 5 years

• Use of hypoglycemic medication

• estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2

• Use of antihypertensive medications

• Hepatic impairment

• Job requiring rotating overnight shifts

• Bariatric surgery within prior 12 months

• Use of hypnotic medications

• Hematocrit <34% (women), <36% (men)