Effects of Lifestyle Intervention in the Biological Aging in Prediabetes

PreDiabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440681
• Other study ID #: IRB log Number:2024-8
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: June 2024
• Source: King Saud University
• Contact: Ahmed S Alenezi, PhD
• Phone: 00966505384985
• Email: 444105554[@]student.ksu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Marker; Structural
• PreDiabetes
• Prediabetic State

Intervention

Other:
• 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.
• counseling on physical activity
Physical activity: Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the rate of measurements of Age marker Albumin post intervention	Change in Albumin (g/L)	6 months
Primary	Change in the rate of measurements of Age marker fasting glucose post intervention	Change in fasting glucose (mmol/L)	6 months
Primary	Change in the rate of measurements of Age marker Creatinine post intervention	Change in Creatinine (umol/L)	6 months
Primary	Change in the rate of measurements of Age marker C-Reactive Protein post intervention	Change in C-Reactive Protein (mg/dL)	6 months
Primary	Change in the rate of measurements of Age marker Alkaline Phosphatase post intervention	Change in Alkaline Phosphatase (U/L)	6 months
Primary	Change in the rate of measurements of Age marker White Blood Cell Count (WBC) post intervention	Change in White Blood Cell Count (WBC) (10^3/uL)	6 months
Primary	Change in the rate of measurements of Age marker Lymphocyte post intervention	Change in Lymphocyte (%)	6 months
Primary	Change in the rate of measurements of Age marker Mean Cell Volume (MCV) post intervention	Change in Mean Cell Volume (MCV) (fL)	6 months
Primary	Change in the rate of measurements of Age marker Red Cell Distribution Width (RDW) post intervention	Change in Red Cell Distribution Width (RDW) (%)	6 months
Secondary	Change in the rate of measurements of Age marker SOST post intervention	Change in SOST(pmol/L)	6 months
Secondary	Change in the rate of measurements of Age marker GDF15 post intervention	Change in GDF15 (10^3 pg/mL)	6 months