Clinical trial NCT06440681: Effects of Lifestyle Intervention in the Biological Aging in Prediabetes
Official title: Effects of a 6-month Lifestyle Intervention Program in the DNAm PhenoAge, SOST, and GDF15 Markers of Biological Aging in Adults With Prediabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PreDiabetes
Marker; Structural
Keywords: DNAm PhenoAge
Lifestyle modification
SOST
DGF-15
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in the rate of measurements of Age marker Albumin post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker fasting glucose post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker Creatinine post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker C-Reactive Protein post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker Alkaline Phosphatase post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker White Blood Cell Count (WBC) post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker Lymphocyte post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker Mean Cell Volume (MCV) post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker Red Cell Distribution Width (RDW) post intervention
timeFrame: 6 months
Secondary outcomes:
measure: Change in the rate of measurements of Age marker SOST post intervention
timeFrame: 6 months
measure: Change in the rate of measurements of Age marker GDF15 post intervention
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: King Saud University
name: Shaun B Sabico, M.D.PhD
role: STUDY_CHAIR
References: