- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368842
Scalp Hair Metabolomics in Severe Obesity
Scalp Hair Metabolomics as a Novel Biomarker of Poor Metabolic Health in Individuals With Severe Obesity
Study Overview
Status
Detailed Description
The investigators will recruit 30 subjects with severe obesity scheduled for bariatric surgery and 30 healthy-weight controls.
Following written informed consent, the investigators will collect the study subject's medical information, conduct a dietary and quality-of-life survey, take body measurements, obtain scalp photos, perform a hair-pull test, collect a hair sample, and conduct muscle strength testing. Controls will be assessed only at baseline. Those with severe obesity will return at 4 ± 2 weeks, 12 ± 4 weeks, and 26 ± 4 weeks following bariatric surgery to repeat the study procedures.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hong Chang Tan, MD PhD
- Phone Number: +65 63214658
- Email: tan.hong.chang@singhealth.com.sg
Study Locations
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-
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Singapore, Singapore
- Recruiting
- Singapore General Hospital
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Contact:
- Hong Chang Tan, MD PhD
- Phone Number: 6563214658
- Email: tan.hong.chang@singhealth.com.sg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All subjects:
- Age 21-70 years
- Ability to provide informed consent
Healthy weight controls:
- BMI of 18.5-24.9 kg/m2
- No chronic disease
- No long-term medications
Severe obesity:
- BMI of > 32.5 kg/m2
- Scheduled to undergo bariatric surgery
Exclusion Criteria:
- Pregnancy
- Any factors likely to limit adherence to study protocol
- Any history of autoimmune or scarring alopecia (eg. alopecia areata, discoid lupus, lichen planopilaris)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Healthy controls
Healthy controls with normal weight
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Severe obestiy
Participants with Severe obesity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amino acid concentration
Time Frame: From enrollment to the end of study duration at 6 months
|
Post-surgery changes in scalp hair amino acid concentration following bariatric surgery
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From enrollment to the end of study duration at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of hair loss
Time Frame: From the time of enrolment until the end of the study at 6 months
|
The severity of hair loss is measured by quantifying the number of hairs lost during the hair pull test
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From the time of enrolment until the end of the study at 6 months
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Scalp hair amino acid concentration (between groups)
Time Frame: At the time of enrollment
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Differences in scalp hair amino acid concentration between controls and those with severe obesity
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At the time of enrollment
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|
Grip strength
Time Frame: From enrollment until the end of the study at 6 months
|
The post-surgery changes in grip strength measured using handgrip dynamometer
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From enrollment until the end of the study at 6 months
|
|
Sit to stand speed
Time Frame: From enrollment until study completion at 6 months
|
Time taken to complete sit to stand test after bariatric surgery
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From enrollment until study completion at 6 months
|
|
Hair-specific Skindex-29 score
Time Frame: From enrollment until study completion at 6 months
|
Hair-specific Skindex-29 quality of life questionnaire score after bariatric surgery.
scores ranging from 0 (no effect) to 100 (effect always experienced)
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From enrollment until study completion at 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hong Chang Tan, Singapore General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGH_Hair01_2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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