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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Completed |
NCT03188263 -
Morning Light Treatment to Improve Glucose Metabolism
|
N/A | |
Recruiting |
NCT03821961 -
18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery
|
N/A | |
Completed |
NCT04303468 -
Intervention With a GABA Supplement in Prediabetics
|
N/A | |
Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
Completed |
NCT03675360 -
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
|
N/A | |
Completed |
NCT01910051 -
Explorative Assessment of Biomarkers in Overweight and Obese Subjects
|
||
Completed |
NCT03527368 -
The Time-Restricted Intake of Meals Study
|
N/A | |
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Completed |
NCT03865342 -
Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT02899390 -
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
|
N/A | |
Suspended |
NCT03240978 -
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
|
N/A | |
Recruiting |
NCT01972113 -
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|
N/A | |
Completed |
NCT01432509 -
Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
|
N/A | |
Completed |
NCT01436916 -
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT00990184 -
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
|
Phase 3 | |
Completed |
NCT00886340 -
A Lifestyle Change Program to Prevent Type 2 Diabetes
|
Phase 2 |