Effects of Lifestyle Intervention in the Biological Aging in Prediabetes

NCT06440681 | Not Yet Recruiting

• 1 other identifier: IRB log Number:2024-8
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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. 1.To determine changes in DNAm PhenoAge of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program.
2. 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.

Conditions

PreDiabetes; Marker; Structural

Keywords

DNAm PhenoAge; Lifestyle modification; SOST; DGF-15

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Change in the rate of measurements of Age marker SOST post intervention

  6 months

• Change in the rate of measurements of Age marker GDF15 post intervention

  6 months

Study Arms (2)

Lifestyle Modification Group (LMP)

ACTIVE COMPARATOR

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; Other: counseling on physical activity

Control group (CG)

PLACEBO COMPARATOR

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

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

Interventions

Providing nutritional counselling 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.

Control group (CG); Lifestyle Modification Group (LMP)

counseling on physical activity OTHER

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

Control group (CG); Lifestyle Modification Group (LMP)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shaun B Sabico, M.D.PhD

  King Saud University

  STUDY CHAIR

Central Study Contacts

Ahmed S Alenezi, PhD

CONTACT

00966505384985; 444105554@student.ksu.edu.sa

Shaun B Sabico, M.D.PhD

CONTACT

00966114675939; ssabico@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There is nothing masked to study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 4, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share