NCT02604095

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

November 5, 2015

Last Update Submit

November 13, 2015

Conditions

Acanthosis NigricansObesity

Keywords

Acanthosis nigricansObesity

Outcome Measures

Primary Outcomes (1)

  • insulin resistance index

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

    12 weeks

Secondary Outcomes (9)

  • Blood pressure

    12 weeks

  • Body weight

    12 weeks

  • Body fat

    12 weeks

  • Neck circumference

    12 weeks

  • Waist circumference

    12 weeks

  • +4 more secondary outcomes

Study Arms (1)

Melatonin

EXPERIMENTAL

Take one table at bedtime.

Dietary Supplement: melatonin

Interventions

melatoninDIETARY_SUPPLEMENT

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

Melatonin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age:18-60 years old;
  • BMI ≥ 28 kg/m2；
  • With acanthosis nigricans。

You may not qualify if:

  • With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

  • 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.

    PMID: 29706998DERIVED

MeSH Terms

Conditions

Acanthosis NigricansObesity

Interventions

Melatonin

Condition Hierarchy (Ancestors)

MelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Shen Qu, Ph.D

    Shanghai 10th People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 13, 2015

Study Start

May 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

CN(1)