Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Obese Men and Women Needed for Research Study to See Effects of Melatonin on Cardiometabolic Risks

Brigham and Women's Hospital Obesity
4 visits over 12 weeks
Estimated Time Commitment
Any Sex/Gender, 18-75 years
May Be Eligible
Payment up to $975
May Be Offered
Survey, Ultrasound, Office visit, Overnight stay, Personal health tracking, Blood draw, Injection or IV, Medication
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

This study will look at the effects of melatonin on the way your pancreas and kidneys work, as well as on your blood vessels and blood pressure. Melatonin is a substance normally found in your blood.

Melatonin is essential for your natural circadian rhythms and sleep-wake cycles. It may also be important for your pancreas and blood vessels to work normally. Melatonin is produced in our body at night. Some people make low amounts of melatonin and this may increase the risk of diabetes, high blood pressure and cardiovascular problems.

In this study, we will look at whether taking melatonin to increase the blood level of melatonin will improve how the pancreas and blood vessels work, and whether it will lower blood pressure. We have asked you to take part in this research study because you are a healthy adult who is overweight or obese.


Why it is important

Observational studies show that low melatonin secretion is independently associated with insulin resistance, type 2 diabetes, hypertension, and inflammation. We propose that low melatonin levels may provide a link between circadian disruption and Cardiovascular Disease (CVD) via several risk factors.


What we hope to accomplish

The goal of this proposal is to elucidate the direct effects of melatonin on CVD risk factors in a randomized double-blind placebo-controlled trial.

Principal Investigator

John P Forman, MD, M.Sc.

Brigham and Women's Hospital

Public Profile

Who can participate

Obese men and women (BMI > 30), 18-75 years old, BP < 150/90

Who cannot participate

diabetic, kidney disease, use of hypoglycemic, cholesterol lowering or antihypertensive drugs, current use of melatonin, sleep medications or natural sleep aids,

What you may be asked to do

If you choose to participate, you will be randomly assigned to take melatonin or placebo (contains no active drug) for 12 weeks.

In this study, you will be asked to attend the following at Brigham and Women's Hospital:
- 1 - 60 minute screening visit
- 2 - 48 hour overnight inpatient hospital stays that are 12 weeks apart
- 1 - 30 minute check up visit

We will also ask you to wear a wrist actigraph (like a fitbit) for a total of 14 days and a blood pressure monitor for 2 days.


Project activities may include:

  • Survey
  • Ultrasound
  • Office visit
  • Overnight stay
  • Personal health tracking
  • Blood draw
  • Injection or IV
  • Medication

Estimated Time Commitment

4 visits over 12 weeks

What You May Get

Those that complete the study will receive $975.

First overnight hospital visit (48 hours)- $250
Check up visit (30 minutes) - $25
Second overnight hospital visit (12 weeks after 1st one, 48 hours) - $700

Location

Brigham and Women's Hospital
75 Francis St, Boston MA 02115

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Brigham and Women's Hospital
221 Longwood, Boston MA 02115

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Travel

  • Accessible by public transportation
  • Parking available
  • Parking reimbursed

Travel and Parking Details

Additional Information

ClinicalTrials.gov Identifier

NCT02681887


Study Phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating Institutions


Funding Source

  • NIH or Other Federal
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