Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440681
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-20
Brief Title:
Effects of Lifestyle Intervention in the Biological Aging in Prediabetes
Sponsor:
King Saud University
Organization:
King Saud University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 httpsthrivouscompagesbiological-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 hoursweek 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
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 httpsthrivouscompagesbiological-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 hoursweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None