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Completed

NCT Number: NCT02604095

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

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

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Key information

Conditions

Acanthosis Nigricans Body Weight Hyperpigmentation Melanosis Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pigmentation Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

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

Primary outcomes

  1. insulin resistance index

    Time frame: 12 weeks

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

Secondary outcomes

  1. Blood pressure

    Time frame: 12 weeks

    Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)

  2. Body weight

    Time frame: 12 weeks

    Body weight (kg)

  3. Body fat

    Time frame: 12 weeks

    Body fat (%)

  4. Neck circumference

    Time frame: 12 weeks

    Neck circumference (cm)

  5. Waist circumference

    Time frame: 12 weeks

    Waist circumference (cm)

  6. Total Cholesterol

    Time frame: 12 weeks

    Total Cholesterol (mmol/L)

  7. Triglyceride

    Time frame: 12 weeks

    Triglyceride (mmol/L)

  8. Low Density Lipoprotein

    Time frame: 12 weeks

    Low Density Lipoprotein (mmol/L)

  9. High Density Lipoprotein

    Time frame: 12 weeks

    High Density Lipoprotein (mmol/L)

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2015
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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