Effects of a 6-month Lifestyle Intervention Program in the DNAm PhenoAge, SOST, and GDF15 Markers of Biological Aging in Adults With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Change in the rate of measurements of Age marker Creatinine post intervention
研究概览
简要总结
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:
- To determine changes in DNAm PhenoAge of elderly Saudis with prediabetes who underwent a 6-month lifestyle modification program.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
There is nothing masked to study
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion Criteria
- •Insulin-dependent diabetes and non-diabetic patients
- •People with diseases that prevent them from participating and doing exercises
排除标准
- 未提供
结局指标
主要结局
Change in the rate of measurements of Age marker Creatinine post intervention
时间窗: 6 months
Change in Creatinine (umol/L)
Change in the rate of measurements of Age marker C-Reactive Protein post intervention
时间窗: 6 months
Change in C-Reactive Protein (mg/dL)
Change in the rate of measurements of Age marker Lymphocyte post intervention
时间窗: 6 months
Change in Lymphocyte (%)
Change in the rate of measurements of Age marker Albumin post intervention
时间窗: 6 months
Change in Albumin (g/L)
Change in the rate of measurements of Age marker Alkaline Phosphatase post intervention
时间窗: 6 months
Change in Alkaline Phosphatase (U/L)
Change in the rate of measurements of Age marker White Blood Cell Count (WBC) post intervention
时间窗: 6 months
Change in White Blood Cell Count (WBC) (10\^3/uL)
Change in the rate of measurements of Age marker Mean Cell Volume (MCV) post intervention
时间窗: 6 months
Change in Mean Cell Volume (MCV) (fL)
Change in the rate of measurements of Age marker Red Cell Distribution Width (RDW) post intervention
时间窗: 6 months
Change in Red Cell Distribution Width (RDW) (%)
Change in the rate of measurements of Age marker fasting glucose post intervention
时间窗: 6 months
Change in fasting glucose (mmol/L)
次要结局
- 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)
研究者
Ahmed Shafi Alenezi
Principle Investigator
King Saud University