Metabolic SyndromeNCT06448806
Mobile Health (M-health) Intervention to Reduce the Epigenetic Signature in Metabolic Syndrome (MetS)
A study testing mobile health lifestyle intervention in people with Metabolic Syndrome and Obesity, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this interventional study is to learn about the improvement in body composition effects of lifestyle intervention in subjects with metabolic syndrome. The main question it aims to answer is: Does life style intervention lower body fat% and gene methylation levels in subjects with metabolic syndrome?… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- mobile health lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jun 2024to 21 May 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Less than 5 kg body weight fluctuation in the 6 months prior to recruitment.
- Ideal body weight for height falling according to the South Asian Criteria as per WHO recommended i.e. Body Mass Index (BMI) of 18.5 to 22.9 kg/m2 (normal-weight) and above 23kg/m2 (overweight/ obese).
- Any one of the following characteristics "according to the modified National Cholesterol Education Program (NCEP) ATPIII guidelines i) waist circumference ii) hyper triglyceridemia (triglycerides ≥150 mg/dl) or low High density lipoprotein (HDL) cholesterol (HDL cholesterol ≤40 mg/dl for men and ≤50 mg/dl for women iii) elevated blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg or current use of antihypertensive drugs) iv) impaired fasting glucose (fasting plasma glucose ≥100mg/dl) v) waist circumference (90 cm in men and 80 cm in women)".
- Have access to a smart phone/mobile and not using the fitness application
Who cannot join
- Age <18 or above 65 year
- Pregnant women
- Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc.
- Unfit for blood testing or no smart phone available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic Signature of Advance Glycation End Products (AGE) and Skin Autofluorescence As a Risk Predictor in Metabolically Healthy and Unhealthy Obese Adults
The goal of this interventional study is to learn about the improvement in body composition effects of lifestyle intervention in subjects with metabolic syndrome. The main question it aims to answer is:
Does life style intervention lower body fat% and gene methylation levels in subjects with metabolic syndrome? Participants will answer survey questions and get blood and body composition testing done at day 0, and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.
Read the detailed description
This is same as above.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- mobile health lifestyle intervention
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile health lifestyle interventionOther
You will be asked to record all dietary and physical activity log for 12 months on an application. Mobile sms reminders will be sent to you on regular basis. At day 0, and 12 months you will be asked to provide 3 ml of blood for the methylation and advance glycation level testing and your weight and body fat percentage will be measured. During this period you will have to follow the lifestyle and diet chart provided to you by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification through m-health | Other | Individuals recruited will be followed for a year and offered lifestyle intervention Receives: Other: mobile health lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in kilograms, height in meter (will be combined to report BMI in kg/m^2)
A weighing scale will be used for this and values recorded on a questionnaire
Measured: one year
Advance glycation end product (U/mL) from serum
This serum biomarker level will be assessed by Enzyme linked immunosorbent assay (ELISA) at the laboratory. Values will be recorded as Units per milliliter on a questionnaire.
Measured: one year
Body fat percentage
Body composition will be measured by Bioelectrical impedance matching (BIA) and computerized topography (CT) scans. The reports will be shared with the participants and values will be recorded on a questionnaire.
Measured: 1 year
Secondary outcomes (2)
Methylation level of genes
From the blood samples collected, DNA will be used to measure the methylation level of genes of interest such as Leptin, POMC, desnutrin etc. These molecular biology testing of this physiological parameter will be conducted in the laboratory and results will be recorded on a questionnaire.
Measured: 1 year
Meal quality and calorie count
Participants will be asked to make a meal diary and write all their food intake and physical activity on a mobile app. They will share their monthly progress with the investigator via WhatsApp (m-health) .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start24 Jun 2024
- Primary completion24 Jun 2024
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia Fatima, Aga Khan University
- Investigators
- Sadia Fatima, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448806
- Sponsor's protocol ID
- Mhealth-Epigen
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Signature of Advance Glycation End Products (AGE) and Skin Autofluorescence As a Risk Predictor in Metabolically Healthy and Unhealthy Obese Adults
- ClinicalTrials.gov ID
- NCT06448806
- Acronym / sponsor ID
- Mhealth-Epigen
- Conditions
- Metabolic Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 7 Jun 2024 (actual)
- 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.
The goal of this interventional study is to learn about the improvement in body composition effects of lifestyle intervention in subjects with metabolic syndrome. The main question it aims to answer is:
Does life style intervention lower body fat% and gene methylation levels in subjects with metabolic syndrome? Participants will answer survey questions and get blood and body composition testing done at day 0, and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.
Detailed description
This is same as above.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification through m-health | Other | Other: mobile health lifestyle interventionIndividuals recruited will be followed for a year and offered lifestyle intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Less than 5 kg body weight fluctuation in the 6 months prior to recruitment.
- Ideal body weight for height falling according to the South Asian Criteria as per WHO recommended i.e. Body Mass Index (BMI) of 18.5 to 22.9 kg/m2 (normal-weight) and above 23kg/m2 (overweight/ obese).
- Any one of the following characteristics "according to the modified National Cholesterol Education Program (NCEP) ATPIII guidelines i) waist circumference ii) hyper triglyceridemia (triglycerides ≥150 mg/dl) or low High density lipoprotein (HDL) cholesterol (HDL cholesterol ≤40 mg/dl for men and ≤50 mg/dl for women iii) elevated blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg or current use of antihypertensive drugs) iv) impaired fasting glucose (fasting plasma glucose ≥100mg/dl) v) waist circumference (90 cm in men and 80 cm in women)".
- Have access to a smart phone/mobile and not using the fitness application
Key exclusion criteria (4 listed)
- Age <18 or above 65 year
- Pregnant women
- Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc.
- Unfit for blood testing or no smart phone available
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 |
|---|---|---|
| mobile health lifestyle interventionYou will be asked to record all dietary and physical activity log for 12 months on an application. Mobile sms reminders will be sent to you on regular basis. At day 0, and 12 months you will be asked to provide 3 ml of blood for the methylation and advance glycation level testing and your weight and body fat percentage will be measured. During this period you will have to follow the lifestyle and diet chart provided to you by the researchers. | Other | Lifestyle modification through m-health |
Primary outcome
Weight in kilograms, height in meter (will be combined to report BMI in kg/m^2)
Time frame: one year
A weighing scale will be used for this and values recorded on a questionnaire
Advance glycation end product (U/mL) from serum
Time frame: one year
This serum biomarker level will be assessed by Enzyme linked immunosorbent assay (ELISA) at the laboratory. Values will be recorded as Units per milliliter on a questionnaire.
Body fat percentage
Time frame: 1 year
Body composition will be measured by Bioelectrical impedance matching (BIA) and computerized topography (CT) scans. The reports will be shared with the participants and values will be recorded on a questionnaire.
2 secondary outcomes
Methylation level of genes
Time frame: 1 year
Meal quality and calorie count
Time frame: 1 year
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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Sadia Fatima, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile health lifestyle intervention in people with Metabolic Syndrome and Obesity, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 4 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 4 Mar 2026. 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 Pakistan. 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?
Weight in kilograms, height in meter (will be combined to report BMI in kg/m^2) (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.