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

November 13, 2015 updated by: Zhang Manna, Shanghai 10th People's Hospital
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin
Take one table at bedtime.
Dietary supplement: melatonin
Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin resistance index
Time Frame: 12 weeks
HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 12 weeks
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
12 weeks
Body weight
Time Frame: 12 weeks
Body weight (kg)
12 weeks
Body fat
Time Frame: 12 weeks
Body fat (%)
12 weeks
Neck circumference
Time Frame: 12 weeks
Neck circumference (cm)
12 weeks
Waist circumference
Time Frame: 12 weeks
Waist circumference (cm)
12 weeks
Total Cholesterol
Time Frame: 12 weeks
Total Cholesterol (mmol/L)
12 weeks
Triglyceride
Time Frame: 12 weeks
Triglyceride (mmol/L)
12 weeks
Low Density Lipoprotein
Time Frame: 12 weeks
Low Density Lipoprotein (mmol/L)
12 weeks
High Density Lipoprotein
Time Frame: 12 weeks
High Density Lipoprotein (mmol/L)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Study Director: Shen Qu, Ph.D, Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melatonin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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