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Effects of combined exercise with and without Nigella sativa on glycemic and lipidemic control, musculoskeletal functions and biomarkers in patients with type 2 diabetes

Comparison of the effects of combined exercise with and without Nigella sativa on glycemic and lipidemic control, musculoskeletal functions and biomarkers (inflammatory and oxidative) in patients with type 2 diabetes mellitus: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18289389
Enrollment
90
Registered
2023-10-27
Start date
2019-10-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM) Nutritional, Metabolic, Endocrine

Interventions

Patients were divided into three groups: exercise-only (EX) group, exercise with NS (EN) group, and control (CON) group. Each group before and after the interventions underwent anthropometric and hemo

Sponsors

Imam Abdulrahman Bin Faisal University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male sex 2. Age range 40 to 60 years 3. Non-active or sedentary lifestyle 4. Non-smoker 5. ADA-based T2DM that has been diagnosed for more than 2 years 6. Without medication modifications during the past 6 months 7. 6.5-9% baseline HbA1c 8. Ready for participation in a monitored exercise programme 9. BMI >30 kg/m² 10. Taking only oral hypoglycaemic medications 11. Free of any serious complications

Exclusion criteria

Exclusion criteria: 1. Foot deformities 2. Heart or lung conditions 3. Uncontrolled blood pressure 4. Current ulcers 5. Additional neuropathic complications

Design outcomes

Primary

MeasureTime frame
Measured before the intervention and 4 weeks after the intervention: 1. Anthropometric measurements including weight in kilograms (kg) and height in centimetres (cm) measured using a Digital Physician Scale (MDW-250L, Adam Equipment Co. Ltd., UK) 2. Metabolic profile (glycaemic and lipidemic profiles): FBG and lipid profile assays (cholesterol, triglyceride, LDL, HDL) carried out on chemistry analyzer DxC 700 AU (Beckman Coulter US, Inc., USA) by colorimetric techniques 3. Systolic blood pressure and diastolic blood pressure measured using GE Healthcare CARESCAPE Vital Signs V100 monitors 4. Oxidative stress markers measured using the Thiobarbituric Acid Reactive Substances (TBARS) test and the Catalase Activity (CAT) test 5. Inflammatory markers measured using the Human Tissue Necrotic Factor - a (TNF-a) test, the Human Interleukin 4 (IL-4) test and the Human Adiponectin (ADP) test

Secondary

MeasureTime frame
Measured before the intervention and 4 weeks after the intervention: 1. Endurance and functional exercise capacity measured using the 6-minute walk test (6MWT) 2. Functional mobility measured using the timed up-and-go test (TUGT) 3. Grip strength measured using a calibrated Jamar dynamometer 4. Functional strength of the lower body was evaluated by the sit-to-stand test (STS)

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026