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Evaluation of the effect of melatonin supplementation on vascular diseases in patients with diabetic nephropathy

Evaluation of the effect of melatonin supplementation on Carotid Intima-Media Thickness, pulse-wave velocity and serum levels of hs-CRP in patients with diabetic nephropathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200527047584N2
Enrollment
60
Registered
2020-07-21
Start date
2020-04-20
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Diabetes. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: melatonin 5 mg (from NUTRALab), 2 capsules daily (half hour before sleep) for 24 weeks. Intervention 2: Control group: placebo, 2 capsules daily (half hour before s

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Approved diabetes Proteinuria > 500 miligram per day GFR between 15-89 mLit/min HbA1c < 7.2 Systolic blood pressure between 140-160 mmHg and Diastolic blood pressure between 90-100 mmHg

Exclusion criteria

Exclusion criteria: Pregnant or Lactating Smoker or alcohol abuser Underlying diseases including cardiovascular diseases, cancer, autoimmune disorders and hypo or hyperthyroidism Using fluvoxamine or antioxidant drugs Urinary tract infection or other diseases that cause proteinuria Night worker

Design outcomes

Primary

MeasureTime frame
Carotid-femoral pulse wave velocity. Timepoint: Before intervention and 24 weeks after intervention. Method of measurement: Color doppler ultrasound.;Carotid Intima-media thickness. Timepoint: Before intervention and 24 weeks after intervention. Method of measurement: Color doppler ultrasound.

Secondary

MeasureTime frame
Hs-CRP level. Timepoint: before and 24 weeks after intervention. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Talari

Kashan University of Medical Sciences

talari_hr@kaums.ac.ir+98 31 5554 0026

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 19, 2026