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

NCT02631148 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2015P002161
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Prediabetic State

Outcome Measures

Primary Outcomes (2)

• Change in Renal Specific Renin-aldosterone-angiotensin System (RAAS) Activity

  renal specific RAAS activity will be assessed via para-aminohippurate (PAH) renal plasma flow testing with captopril

  6 weeks

• Change in Systemic Renin-aldosterone-angiotensin System (RAAS) Activity

  systemic RAAS will be assessed by plasma renin activity (PRA), angiotensin II (Ang II) levels and urine aldosterone

  6 weeks

Secondary Outcomes (2)

• Change in Glucose Metabolism

  6 weeks

• Change in Central Blood Pressure

  6 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo tablet identical to Circadin by mouth each day before bedtime for 6 weeks

Drug: Placebo

Interventions

Melatonin DRUG

2mg controlled release melatonin tablet

Also known as: Circadin

Melatonin

Placebo DRUG

placebo tablet identical to circadin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Ciaran McMullan
• Organization: Brigham and Women's Hosptial

mcmullcj@gmail.com

617 732 5500

Study Officials

• Ciaran J McMullan, MD, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)