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

Primary Purpose

Acanthosis Nigricans, Obesity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
melatonin
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acanthosis Nigricans focused on measuring Acanthosis nigricans, Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Tenth People' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melatonin

Arm Description

Take one table at bedtime.

Outcomes

Primary Outcome Measures

insulin resistance index
HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5

Secondary Outcome Measures

Blood pressure
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Body weight
Body weight (kg)
Body fat
Body fat (%)
Neck circumference
Neck circumference (cm)
Waist circumference
Waist circumference (cm)
Total Cholesterol
Total Cholesterol (mmol/L)
Triglyceride
Triglyceride (mmol/L)
Low Density Lipoprotein
Low Density Lipoprotein (mmol/L)
High Density Lipoprotein
High Density Lipoprotein (mmol/L)

Full Information

First Posted
November 5, 2015
Last Updated
November 13, 2015
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02604095
Brief Title
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Official Title
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acanthosis Nigricans, Obesity
Keywords
Acanthosis nigricans, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Take one table at bedtime.
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin
Intervention Description
Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.
Primary Outcome Measure Information:
Title
insulin resistance index
Description
HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Time Frame
12 weeks
Title
Body weight
Description
Body weight (kg)
Time Frame
12 weeks
Title
Body fat
Description
Body fat (%)
Time Frame
12 weeks
Title
Neck circumference
Description
Neck circumference (cm)
Time Frame
12 weeks
Title
Waist circumference
Description
Waist circumference (cm)
Time Frame
12 weeks
Title
Total Cholesterol
Description
Total Cholesterol (mmol/L)
Time Frame
12 weeks
Title
Triglyceride
Description
Triglyceride (mmol/L)
Time Frame
12 weeks
Title
Low Density Lipoprotein
Description
Low Density Lipoprotein (mmol/L)
Time Frame
12 weeks
Title
High Density Lipoprotein
Description
High Density Lipoprotein (mmol/L)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Qu, Ph.D
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Tenth People' Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29706998
Citation
Sun H, Wang X, Chen J, Gusdon AM, Song K, Li L, Qu S. Melatonin Treatment Improves Insulin Resistance and Pigmentation in Obese Patients with Acanthosis Nigricans. Int J Endocrinol. 2018 Mar 12;2018:2304746. doi: 10.1155/2018/2304746. eCollection 2018.
Results Reference
derived

Learn more about this trial

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

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