Effects of Lifestyle Intervention in the Biological Aging in Prediabetes

Effects of a 6-month Lifestyle Intervention Program in the DNAm PhenoAge, SOST, and GDF15 Markers of Biological Aging in Adults With Prediabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PreDiabetes; Marker; Structural
• Intervention / Treatment: Other: Providing nutritional counselling; Other: counseling on physical activity

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed S Alenezi, PhD; Phone Number: 00966505384985; Email: 444105554@student.ksu.edu.sa
• Study Contact Backup: Name: Shaun B Sabico, M.D.PhD; Phone Number: 00966114675939; Email: ssabico@ksu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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.; Other: counseling on physical activity; Physical activity: Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)
Placebo Comparator: Control group (CG); They are people who will not follow the lifestyle modification program or they did not know about this program	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.; Other: counseling on physical activity; Physical activity: Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the rate of measurements of Age marker Albumin post intervention	Change in Albumin (g/L)	6 months
Change in the rate of measurements of Age marker fasting glucose post intervention	Change in fasting glucose (mmol/L)	6 months
Change in the rate of measurements of Age marker Creatinine post intervention	Change in Creatinine (umol/L)	6 months
Change in the rate of measurements of Age marker C-Reactive Protein post intervention	Change in C-Reactive Protein (mg/dL)	6 months
Change in the rate of measurements of Age marker Alkaline Phosphatase post intervention	Change in Alkaline Phosphatase (U/L)	6 months
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
Change in the rate of measurements of Age marker Lymphocyte post intervention	Change in Lymphocyte (%)	6 months
Change in the rate of measurements of Age marker Mean Cell Volume (MCV) post intervention	Change in Mean Cell Volume (MCV) (fL)	6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the rate of measurements of Age marker SOST post intervention	Change in SOST(pmol/L)	6 months
Change in the rate of measurements of Age marker GDF15 post intervention	Change in GDF15 (10^3 pg/mL)	6 months

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Study Chair: Shaun B Sabico, M.D.PhD, King Saud University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Lifestyle modification; SOST; DNAm PhenoAge; DGF-15
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IRB log Number:2024-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No