Evaluation of Anti hyperglycemic Effect of internal septum of Juglans regia in patients with diabetes mellitus type II: A Double blind Randomized Clinical Trial

Phase 3

• Conditions: E11.9; Type 2 diabetes mellitus.; Type 2 diabetes mellitus without complications

• Registration Number: IRCT20201229049877N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Obtain consent from patients
Age between 25 and 70 year old
HbA1C=7% and less than 9% and FPG = 130-250 mg / dl
Take metformin and/or other anti-diabetic agents (in maximum and constant dose for three months) or metformin alone (in maximum and constant dose for three months)
Constant diet and physical activity during the study (according to a questionnaire translated and validated into Persian)
The patient's anti-diabetic medication regimen remained constant during the study
No allergies to walnuts

Exclusion Criteria

History of walnut allergy
Immune system defects
Pregnancy and lactation
Cardiovascular disease (coronary artery ischemia, EF <45%)
Take medications that change blood glucose levels (corticosteroids, tacrolimus, anti-AIDS drugs, antipsychotic drugs)
Uncontrolled thyroid disease
Acute infection
History of diabetic ketoacidosis
eGFR<60 ml/min
Acute hepatitis (increase in ALT and AST to more than 10 to 20 times normal)
cirrhosis
Proliferative retinopathy
Severe weight loss (at least 10% over 6 months)
Consumption of any other medicine and herbal products, including walnuts

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decreases of hemogllubin A1C (HbA1C)c. Timepoint: 0 and 12 weeks after initiation of the drug. Method of measurement: serum level measurement.