Effects of Lifestyle Intervention in the Biological Aging in Prediabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PreDiabetes Marker; Structural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 6-month lifestyle modification program will be launched at primary health centers in Arar, Saudi Arabia. 500 participants will be involved and all participants will be advised to: Reducing weight (5% of the basic weight), Exercise (4 hours/week), Moderate fat consumption (total fat 30% of total energy intake and saturated fat 10%). % of total energy consumed), A diet rich in fiber (15 g/1000 calories). Participants will receive individual, detailed, ongoing nutritional counseling by the study dietitian every two weeks. They will also be encouraged to participate in physical activities. The table below shows the detailed intervention for both groups.

Finally, the participants will be divided into two groups:

Lifestyle Modification Group (LMP): those who agreed and followed the previous instructions and advice. Control group (CG): those who did not receive health education or did not follow previous instructions or advice.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

There is nothing masked to study

Study Groups

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Lifestyle Modification Group (LMP)

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)

Group Type ACTIVE_COMPARATOR

Providing nutritional counselling

Intervention Type OTHER

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.

Participants will receive individual, detailed, ongoing nutritional counseling by the study dietitian every two weeks.

counseling on physical activity

Intervention Type OTHER

Physical activity:

Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)

Control group (CG)

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

Group Type PLACEBO_COMPARATOR

Providing nutritional counselling

Intervention Type OTHER

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.

Participants will receive individual, detailed, ongoing nutritional counseling by the study dietitian every two weeks.

counseling on physical activity

Intervention Type OTHER

Physical activity:

Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)

Interventions

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Providing nutritional counselling

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.

Participants will receive individual, detailed, ongoing nutritional counseling by the study dietitian every two weeks.

Intervention Type OTHER

counseling on physical activity

Physical activity:

Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)

Intervention Type OTHER

Eligibility Criteria

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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