Effect of lifestyle changes on metabolic health and PCSK9 levels in people with prediabetes

ISRCTN	ISRCTN10701142
DOI	https://doi.org/10.1186/ISRCTN10701142
Sponsor	Ankara City Hospital
Funder	Investigator initiated and funded

Submission date: 21/04/2026
Registration date: 23/04/2026
Last edited: 23/04/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Yunus Saglar
Public, Scientific, Principal investigator

Ankara City Hospital
Ankara
06800
Türkiye

Phone	+90 5334518933
Email	yunussglr@gmail.com

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Treatment
Scientific title	Lifestyle intervention improves metabolic parameters but does not modify PCSK9 levels in prediabetes: a prospective cohort study
Study objectives
Ethics approval(s)	Approved 27/12/2023, Clinical Research Ethics Committee No. 2 (Ankara City Hospital, Ankara, 06800, Türkiye; +90 312 552 60 00; ankara.sehirhastanesi@saglik.gov.tr), ref: E2-23-5663
Health condition(s) or problem(s) studied	Prediabetes, insulin resistance, metabolic dysregulation
Intervention	Lifestyle intervention consisting of individualized medical nutrition therapy and a structured exercise program. Dietary intervention included personalized caloric planning based on age, sex, and body mass index, with a Mediterranean-style diet emphasizing whole grains, fruits, vegetables, legumes, and healthy fats. Participants were advised to limit saturated fat intake (<10% of total energy), avoid refined carbohydrates, and increase dietary fiber intake. Exercise intervention consisted of at least 150 minutes per week of moderate-intensity aerobic physical activity (3–6 METs), such as brisk walking. The program was progressive and individualized, including warm-up, active, and cool-down phases. Participants were followed for 3 months with regular monitoring and reinforcement of adherence through clinic visits and telephone contact.
Intervention type	Behavioural
Primary outcome measure(s)	Serum PCSK9 levels measured using enzyme-linked immunosorbent assay (ELISA), expressed in ng/mL at baseline and at 3 months following completion of lifestyle intervention
Key secondary outcome measure(s)	Anthropometric measurements (body weight, BMI, waist circumference, body fat percentage) measured using standardized clinical methods at baseline and at 3 months following completion of lifestyle intervention Biochemical parameters (fasting plasma glucose, HbA1c, lipid profile) measured using automated laboratory analyzers; at baseline and at 3 months following completion of lifestyle intervention Insulin resistance indices (HOMA-IR, TyG index) measured using standard formulas at baseline and at 3 months following completion of lifestyle intervention
Completion date	07/11/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	132
Total final enrolment	132
Key inclusion criteria	1. Adults aged 18–65 years 2. Confirmed diagnosis of prediabetes based on ADA criteria (HbA1c 5.7–6.4%) 3. Ability and willingness to comply with lifestyle intervention and follow-up assessments 4. Provision of written informed consent
Key exclusion criteria	1. Diagnosis of type 2 diabetes mellitus 2. Use of lipid-lowering medications (including statins or PCSK9 inhibitors) 3. Chronic liver or kidney disease 4. Active infection or inflammatory disease 5. Malignancy 6. Pregnancy or lactation
Date of first enrolment	27/12/2023
Date of final enrolment	07/11/2024

Locations

Countries of recruitment

Türkiye

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	Individual participant data underlying the results reported in this study (including de-identified demographic, clinical, and laboratory data) will be available from the corresponding author upon reasonable request, following publication. Data will be shared with researchers who provide a methodologically sound proposal, in accordance with institutional policies and applicable data protection regulations.

Individual participant data (IPD) Intention to share

Yes

IPD sharing plan

Individual participant data underlying the results reported in this study (including de-identified demographic, clinical, and laboratory data) will be available from the corresponding author upon reasonable request, following publication. Data will be shared with researchers who provide a methodologically sound proposal, in accordance with institutional policies and applicable data protection regulations.

Editorial Notes

23/04/2026: Trial's existence confirmed by Clinical Research Ethics Committee No. 2 Ankara City Hospital.