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Effects of Lifestyle Intervention in the Biological Aging in Prediabetes

ConditionsPreDiabetesMarker; Structural
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorKing Saud University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Insulin-dependent diabetes and non-diabetic patients

People with diseases that prevent them from participating and doing exercises

Trial design

Design model

Parallel

Treatments tested in this trial

  • Providing nutritional counselling

    Other intervention

    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.

  • counseling on physical activity

    Other intervention

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Lifestyle Modification Group (LMP)Active comparator 2 interventions
Group B: Control group (CG)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in the rate of measurements of Age marker Albumin post intervention

Change in Albumin (g/L)

Time frame
6 months
2

Change in the rate of measurements of Age marker fasting glucose post intervention

Change in fasting glucose (mmol/L)

Time frame
6 months
3

Change in the rate of measurements of Age marker Creatinine post intervention

Change in Creatinine (umol/L)

Time frame
6 months
4

Change in the rate of measurements of Age marker C-Reactive Protein post intervention

Change in C-Reactive Protein (mg/dL)

Time frame
6 months

Secondary outcomes

1

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

Change in SOST(pmol/L)

Time frame
6 months
2

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

Change in GDF15 (10\^3 pg/mL)

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Saud University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: