Obesity Clinical Trial
Official title:
Effect of Melatonin on Cardiometabolic Risk- FULL
In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity
(BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive
either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour
before bed. The investigators will assess melatonin's effect on insulin sensitivity by
performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured
using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating
melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal blood
pressure, and potential intermediates including endothelial function using brachial
ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion,
and renin-angiotensin system activation using measurements of plasma renin activity,
angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate
melatonin supplementation's effect on cellular cytokine and CC family chemokine expression as
well as high sensitivity C-reactive protein, IL-6, and TNF-α.
There will be a 24 week cohort phase as an extension of the trial. This will be an open-label
prospective study of 50 subjects recruited from the trial who will take 2 mg of
controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At
the end of the cohort-phase (36 weeks after entry in the trial), the investigators will again
assess the extended use of melatonin supplementation on 24-hour BP, and glycemic control
(HbA1, fasting glucose).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age =18 years - body mass index (BMI) >30 - HbA1c 5.4-6.4% - if hypertensive, BP <150/90 Exclusion Criteria: - Use of a melatonin supplement - Current use of anticoagulants - Use of hypoglycemic or antihypertensive meds - Current or prior history of diabetes mellitus, or random serum glucose = 200 mg/dL - Major bleeding event in the past 60 days - Recent (past 2 weeks) or upcoming travel across time zones - Known obstructive sleep apnea or use of continuous positive airway pressure - Known heparin allergy - Hepatic impairment - Estimated GFR <60 mL/min/1.73m2 - Pregnant - Job requires rotating night shifts - Preexisting lung disease requiring oxygen - Active chronic or acute infection - Preexisting CVD - Known melatonin allergy - Bariatric surgery within the prior 12 months - Preexisting hemoglobinopathy - Use of weekly or daily NSAID for chronic pain - Use of cholesterol lowering medications - Active or uncontrolled psychotic disorder - Use of hypnotic medications - Active or uncontrolled bipolar illness - Active or uncontrolled depression - Recent (within the past three months) blood donation or plan to donate blood during study period - Use of a phosphodiesterase inhibitor - Active malignancy within the prior 5 years - Hypertension (>150/90) - Currently lactating (women) - History of stroke - Hematocrit <36 (women) or <41 (men) - Thrombocytopenia or other bleeding disorders - Surgery in the past 60 days |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in insulin sensitivity | measure insulin sensitivity using hyperinsulinemic clamp | 12 weeks | |
Primary | change in beta-islet cell function | measure beta-iset cell function measured using a hyperglycemic clamp | 12 weeks | |
Secondary | change in 24 hour ambulatory blood pressure | evaluate the effect of supplementation on 24-hour ambulatory blood pressure | 12 weeks | |
Secondary | change in nocturnal blood pressure | evaluate the effect of supplementation nocturnal blood pressure | 12 weeks | |
Secondary | change in endothelial dependent vasodilation | Measurements of the brachial diameter will be made under basal conditions and during reactive hyperemia following five minutes of ischemic stimulus | 12 weeks | |
Secondary | change in endothelial independent vasodilation | measuring brachial artery diameter under basal conditions and 3 minutes following the administration of sublingual nitroglycerine (0.4mg) | 12 weeks | |
Secondary | change in catecholamine production | using 24 hour urine collection, measure catecholamines from (epinephrine, norepinephrine and dopamine) using a RIA | 12 weeks | |
Secondary | change in plasma renin level | effect of melatonin on RAS | 12 weeks | |
Secondary | change in angiotensin II level | effect of melatonin on RAS | 12 weeks | |
Secondary | change in cellular cytokine level | effect of melatonin on inflammatory markers | 12 weeks | |
Secondary | change in CC family chemokine expression | effect of melatonin on inflammatory markers | 12 weeks | |
Secondary | change in high sensitivity CRP | effect of melatonin on inflammatory markers | 12 weeks | |
Secondary | change in IL-6 level | effect of melatonin on inflammatory markers | 12 weeks | |
Secondary | change in TNF-alpha | effect of melatonin on inflammatory markers | 12 weeks |
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