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OpenTrials
Completed

NCT Number: NCT06448806

Mobile Health (M-health) Intervention to Reduce the Epigenetic Signature in Metabolic Syndrome (MetS)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DBBS

Karachi, Sindh, 74800, Pakistan

About this study

This is same as above.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

mobile health lifestyle intervention

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Methylation level of genes

    Time frame: 1 year

    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.

  2. Meal quality and calorie count

    Time frame: 1 year

    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) .

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Epigenetic Signature of Advance Glycation End Products (AGE) and Skin Autofluorescence As a Risk Predictor in Metabolically Healthy and Unhealthy Obese Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Mar 4, 2026

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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