Acanthosis NigricansNCT02604095
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
A study testing melatonin in people with Acanthosis Nigricans and Obesity, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acanthosis Nigricans, Obesity
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age:18-60 years old;
- BMI ≥ 28 kg/m2；
- With acanthosis nigricans。
Who cannot join
- With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People' Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.
Read the detailed description
The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.
- Conditions
- Acanthosis Nigricans, Obesity
- Being tested
- melatonin
- Keywords
- Acanthosis nigricans, Obesity
- Medical subject headings
- Acanthosis Nigricans, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDietary supplement
Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Take one table at bedtime. Receives: Dietary Supplement: melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance index
HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5
Measured: 12 weeks
Secondary outcomes (9)
Blood pressure
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Measured: 12 weeks
Body weight
Body weight (kg)
Measured: 12 weeks
Body fat
Body fat (%)
Measured: 12 weeks
Neck circumference
Neck circumference (cm)
Measured: 12 weeks
Waist circumference
Waist circumference (cm)
Measured: 12 weeks
Total Cholesterol
Total Cholesterol (mmol/L)
Measured: 12 weeks
Triglyceride
Triglyceride (mmol/L)
Measured: 12 weeks
Low Density Lipoprotein
Low Density Lipoprotein (mmol/L)
Measured: 12 weeks
High Density Lipoprotein
High Density Lipoprotein (mmol/L)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acanthosis NigricansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Shen Qu, Ph.D, Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604095
- Sponsor's protocol ID
- Melatonin
- Status last verified
- Nov 2015
- First submitted
- 5 Nov 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29706998
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism
- ClinicalTrials.gov ID
- NCT02604095
- Acronym / sponsor ID
- Melatonin
- Conditions
- Acanthosis Nigricans, Obesity
- Keywords
- Acanthosis nigricans, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Dietary Supplement: melatoninTake one table at bedtime. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age:18-60 years old;
- BMI ≥ 28 kg/m2；
- With acanthosis nigricans。
Key exclusion criteria (1 listed)
- With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninTake one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks. | Dietary supplement | Melatonin |
Primary outcome
insulin resistance index
Time frame: 12 weeks
HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5
9 secondary outcomes
Blood pressure
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Body fat
Time frame: 12 weeks
Neck circumference
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Total Cholesterol
Time frame: 12 weeks
Triglyceride
Time frame: 12 weeks
Low Density Lipoprotein
Time frame: 12 weeks
High Density Lipoprotein
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Derived from this study: PubMed 29706998Sun 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.
Related trials for Acanthosis Nigricans
Not yet recruitingPhase 1
Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans
Acanthosis Nigricans
Active, not recruitingPhase 2
Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance
Severe Insulin Resistance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Qu, Ph.D study director
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin in people with Acanthosis Nigricans and Obesity, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.