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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Obesity, Prediabetic State

In brief

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.

Key facts

Study ID

NCT02631148

Run by

Brigham and Women's Hospital

People needed

12

Starts

2016-01-01

Expected to finish

2017-12-31

Last updated by the study team

2021-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) ≥ 30 kg/m2
• Hemoglobin A1c (HbA1c) 6.7-6.4%
• Self reported sleep < 7 hours per night

You may not qualify if…

• 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)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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