Effects of Lifestyle Intervention in the Biological Aging in Prediabetes

King Saud University

Status: Not yet enrolling

Conditions: Marker; Structural; PreDiabetes

Treatments: Other: Providing nutritional counselling; Other: counseling on physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06440681

IRB log Number:2024-8

Details and patient eligibility

About

Lifestyle modifications, including dietary changes and increased physical activity, play a crucial role in controlling complications to reduce or eliminate them. As well as controlling disturbances in biochemical markers such as DNAm PhenoAge, and signs of aging such as circulating sclerostin (SOST) and growth differentiation factor 15 (GDF15). This study seeks to address this dilemma by focusing on specific groups of elderly Saudis with prediabetes . Lifestyle changes in elderly Saudis with prediabetes show promise in reducing or eliminating complications. The potential insights derived from this research extend beyond academia, offering tangible benefits for clinical practice and public health

The proposed study will be implemented to achieve the following objective:

1. To determine changes in DNAm PhenoAge of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program.
2. To determine changes in other candidate senescence markers such as circulating sclerostin (SOST) and growth differentiation factor 15 (GDF15) of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program.

Full description

Participants will be received at all healthcare centers in Arar, Kingdom of Saudi Arabia. They will be informed about the lifestyle modification intervention programme. The interview will take place in a designated and prepared place.

If approved, informed consent is signed. The procedures begin with filling out questionnaires and basic assessments include anthropometric, blood pressure and blood pressure measurements. The anthropometric measurements will be performed by well-trained medical staff. Height (m) and weight (kg) will be measured in light clothing without shoes. Waist, hip, circumference (cm) will be measured using a standard tape measure. BMI will be calculated by dividing weight in kilograms by the square of height in metres. Your blood pressure will be measured at each visit after adequate rest.

Dietary intake will be assessed through a validated food frequency questionnaire. Assessments will be repeated twice (at baseline and 6 months) in both groups. Fasting blood samples will then be collected using a sterile blood collection device to perform blood tests for biological age using self-analyzers in the internal laboratory of the participating primary health care centers. Tests will include complete blood count, serum albumin, creatinine, fasting glucose, C-reactive protein, alkaline phosphatase and other markers of aging such as SOST and DGF-15. Through these tests, the DNAm PhenoAge will be calculated through an online platform (https://thrivous.com/pages/biological-age Calculator).

In light of the results, participants will be included or excluded, and participants included in the program will continue with us through follow-up with nutritional awareness. 500 participants will be involved and all participants will be advised to:

Weight loss (5% of basic weight), exercise (4 hours/week), moderate fat consumption, and a diet rich in fiber.

5- Participants will receive individual, detailed and ongoing nutritional counseling through the study dietitian every two weeks, and they will also be encouraged to participate in physical activities. Table The detailed intervention for both groups is shown below. The measurements and analyzes will be repeated a few months after the beginning, and based on this, the Lifestyle Modification Group (LMP) will be determined: those who agreed and followed the previous instructions and advice.

The control group (CG): They are those who did not receive health education or did not follow previous instructions or advice.

Enrollment: 500 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Clinical diagnosis of pre-diabetes for all Saudis aged 30 years and above, males and females
2. They must be able to exercise and be able to follow a diet

Exclusion Criteria

1. Insulin-dependent diabetes and non-diabetic patients
2. People with diseases that prevent them from participating and doing exercises

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups, including a placebo group

Lifestyle Modification Group (LMP)

Active Comparator group

Description:

They are the people who will follow the lifestyle modification program, which is: Dietary counseling and monitoring: reduce fat intake (30% of total energy and saturated fat 10% of total energy) and increase fiber intake (15 g/1000 kcal) in the diet Physical activity: moderate exercise (150 minutes/week)

Treatment:

Other: counseling on physical activity

Other: Providing nutritional counselling

Control group (CG)

Placebo Comparator group

Description:

They are people who will not follow the lifestyle modification program or they did not know about this program

Treatment:

Other: counseling on physical activity

Other: Providing nutritional counselling