Evaluation of the effect of melatonin supplementation on vascular diseases in patients with diabetic nephropathy
Phase 3
- Conditions
- Diabetes.Type 2 diabetes mellitus
- Registration Number
- IRCT20200527047584N2
- Lead Sponsor
- Kashan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hs-CRP level. Timepoint: before and 24 weeks after intervention. Method of measurement: Blood test.