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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448806
• Other study ID #: Mhealth-Epigen
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 21, 2025

Study information

• Verified date: June 2024
• Source: Aga Khan University
• Contact: Sadia Fatima, PhD
• Phone: +9234864147
• Email: sadia.fatima[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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? Participants will answer survey questions and get blood and body composition testing done at day 0, at 6 months and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.

Description:

This is same as above.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 21, 2025
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Less than 5 kg body weight fluctuation in the 6 months prior to recruitment.

2. 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).

3. 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)".

4. Have access to a smart phone/mobile and not using the fitness application

Exclusion Criteria:

1. Age <18 or above 65 year

2. Pregnant women

3. Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc.

4. Unfit for blood testing or no smart phone available

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

Other:
• mobile health lifestyle intervention
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, at 6th 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.

Locations

Country	Name	City	State
Pakistan	DBBS	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Primary	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.	one year
Primary	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.	1 year
Secondary	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, Ghrelin, fat mass obesity, chemerin etc. These molecular biology testing of this physiological parameter will be conducted in the laboratory and results will be recorded on a questionnaire.	1 year
Secondary	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) .	1 year