NCT02604095CompletedNot Applicable
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Shanghai 10th People's Hospital1 site in 1 country16 target enrollmentStarted: May 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- insulin resistance index
Study Overview
Brief Summary
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.
Detailed Description
The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age:18-60 years old;
- •BMI ≥ 28 kg/m2；
- •With acanthosis nigricans。
Exclusion Criteria
- •With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.
Arms & Interventions
Melatonin
Experimental
Take one table at bedtime.
Intervention: melatonin (Dietary Supplement)
Outcomes
Primary Outcomes
insulin resistance index
Time Frame: 12 weeks
HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5
Secondary Outcomes
- Neck circumference(12 weeks)
- Triglyceride(12 weeks)
- Low Density Lipoprotein(12 weeks)
- Blood pressure(12 weeks)
- Waist circumference(12 weeks)
- High Density Lipoprotein(12 weeks)
- Body weight(12 weeks)
- Body fat(12 weeks)
- Total Cholesterol(12 weeks)
Investigators
Zhang Manna
Professor
Shanghai 10th People's Hospital
Study Sites (1)
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