PreDiabetesNCT06440681
Effects of Lifestyle Intervention in the Biological Aging in Prediabetes
A study testing Providing nutritional counselling and counseling on physical activity in people with PreDiabetes and Marker; Structural, run by King Saud University.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- PreDiabetes, Marker; Structural
- What is being tested?
- Providing nutritional counselling and counseling on physical activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insulin-dependent diabetes and non-diabetic patients
- People with diseases that prevent them from participating and doing exercises
Trial locations and contacts
No sites are listed yet.
About this study
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:
- 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.
Read the 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 (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.
- Conditions
- PreDiabetes, Marker; Structural
- Being tested
- Providing nutritional counselling, counseling on physical activity
- Keywords
- DNAm PhenoAge, Lifestyle modification, SOST, DGF-15
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing nutritional counsellingOther
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 activityOther
Physical activity:
Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Providing nutritional counselling; Other: counseling on physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the rate of measurements of Age marker Albumin post intervention
Change in Albumin (g/L)
Measured: 6 months
Change in the rate of measurements of Age marker fasting glucose post intervention
Change in fasting glucose (mmol/L)
Measured: 6 months
Change in the rate of measurements of Age marker Creatinine post intervention
Change in Creatinine (umol/L)
Measured: 6 months
Change in the rate of measurements of Age marker C-Reactive Protein post intervention
Change in C-Reactive Protein (mg/dL)
Measured: 6 months
Change in the rate of measurements of Age marker Alkaline Phosphatase post intervention
Change in Alkaline Phosphatase (U/L)
Measured: 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)
Measured: 6 months
Change in the rate of measurements of Age marker Lymphocyte post intervention
Change in Lymphocyte (%)
Measured: 6 months
Change in the rate of measurements of Age marker Mean Cell Volume (MCV) post intervention
Change in Mean Cell Volume (MCV) (fL)
Measured: 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) (%)
Measured: 6 months
Secondary outcomes (2)
Change in the rate of measurements of Age marker SOST post intervention
Change in SOST(pmol/L)
Measured: 6 months
Change in the rate of measurements of Age marker GDF15 post intervention
Change in GDF15 (10^3 pg/mL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shafi Alenezi, King Saud University
- Investigators
- Shaun B Sabico, M.D.PhD, Study chair, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440681
- Sponsor's protocol ID
- IRB log Number:2024-8
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alenezi A, Sabico S, Alnaami AM, Hussain SD, Elrobh MS, Al-Daghri NM. Structured lifestyle modification and biological aging: effects on PhenoAge, sclerostin, and GDF-15 in arab adults with prediabetes. Front Aging. 2026 Sep 10;7:1809697. doi: 10.3389/fragi.2026.1809697. eCollection 2026.
PubMed 42787268
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06440681
- Acronym / sponsor ID
- IRB log Number:2024-8
- Conditions
- PreDiabetes, Marker; Structural
- Keywords
- DNAm PhenoAge, Lifestyle modification, SOST, DGF-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification Group (LMP) | Active comparator | Other: Providing nutritional counselling, Other: counseling on physical activityThey 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) |
| Control group (CG) | Placebo comparator | Other: Providing nutritional counselling, Other: counseling on physical activityThey are people who will not follow the lifestyle modification program or they did not know about this program |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Insulin-dependent diabetes and non-diabetic patients
- People with diseases that prevent them from participating and doing exercises
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providing nutritional counsellingDietary 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. | Other | Control group (CG), Lifestyle Modification Group (LMP) |
| counseling on physical activityPhysical activity: Participants will also be encouraged to participate in physical activities. moderate exercise (150 minutes/week) | Other | Control group (CG), Lifestyle Modification Group (LMP) |
Primary outcome
Change in the rate of measurements of Age marker Albumin post intervention
Time frame: 6 months
Change in Albumin (g/L)
Change in the rate of measurements of Age marker fasting glucose post intervention
Time frame: 6 months
Change in fasting glucose (mmol/L)
Change in the rate of measurements of Age marker Creatinine post intervention
Time frame: 6 months
Change in Creatinine (umol/L)
Change in the rate of measurements of Age marker C-Reactive Protein post intervention
Time frame: 6 months
Change in C-Reactive Protein (mg/dL)
Change in the rate of measurements of Age marker Alkaline Phosphatase post intervention
Time frame: 6 months
Change in Alkaline Phosphatase (U/L)
Change in the rate of measurements of Age marker White Blood Cell Count (WBC) post intervention
Time frame: 6 months
Change in White Blood Cell Count (WBC) (10^3/uL)
Change in the rate of measurements of Age marker Lymphocyte post intervention
Time frame: 6 months
Change in Lymphocyte (%)
Change in the rate of measurements of Age marker Mean Cell Volume (MCV) post intervention
Time frame: 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
Time frame: 6 months
Change in Red Cell Distribution Width (RDW) (%)
2 secondary outcomes
Change in the rate of measurements of Age marker SOST post intervention
Time frame: 6 months
Change in the rate of measurements of Age marker GDF15 post intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 42787268Alenezi A, Sabico S, Alnaami AM, Hussain SD, Elrobh MS, Al-Daghri NM. Structured lifestyle modification and biological aging: effects on PhenoAge, sclerostin, and GDF-15 in arab adults with prediabetes. Front Aging. 2026 Sep 10;7:1809697. doi: 10.3389/fragi.2026.1809697. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun B Sabico, M.D.PhD study chair
King Saud University
Questions about this trial
What is this clinical trial studying?
A study testing Providing nutritional counselling and counseling on physical activity in people with PreDiabetes and Marker; Structural, run by King Saud University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed S Alenezi, PhD (00966505384985, 444105554@student.ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the rate of measurements of Age marker Albumin post intervention (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.