Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism

Obesity Clinical Trial

Official title:

Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604095
• Other study ID #: Melatonin
• Status: Completed
• Phase: N/A
• First received: November 5, 2015
• Last updated: November 13, 2015
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.

Description:

The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acanthosis Nigricans
• Obesity

Intervention

Dietary Supplement:
• melatonin
Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.

Locations

Country	Name	City	State
China	Shanghai Tenth People' Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance index	HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5	12 weeks	Yes
Secondary	Blood pressure	Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)	12 weeks	Yes
Secondary	Body weight	Body weight (kg)	12 weeks	Yes
Secondary	Body fat	Body fat (%)	12 weeks	Yes
Secondary	Neck circumference	Neck circumference (cm)	12 weeks	Yes
Secondary	Waist circumference	Waist circumference (cm)	12 weeks	Yes
Secondary	Total Cholesterol	Total Cholesterol (mmol/L)	12 weeks	Yes
Secondary	Triglyceride	Triglyceride (mmol/L)	12 weeks	Yes
Secondary	Low Density Lipoprotein	Low Density Lipoprotein (mmol/L)	12 weeks	Yes
Secondary	High Density Lipoprotein	High Density Lipoprotein (mmol/L)	12 weeks	Yes