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Clinical Trial Details

Trial ID: L3709
Source ID: NCT05918068
Associated Drug: Metformin 500 Mg/Day
Title: Pyridoxine Effect on the Blood Glucose Level in Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin 500 mg/day|COMBINATION_PRODUCT: Metformin 500 mg/day plus vitamin B6 300 mg/day|OTHER: non-pharmacological therapy
Outcome Measures: Primary: Fasting plasma glucose (FPG)., A fasting plasma glucose test, also known as a fasting glucose test (FGT), is a test that can be used to help diagnose diabetes or pre-diabetes.The expected values for normal fasting blood glucose concentration are between 70 mg/dL (3.9 mmol/L) and 100 mg/dL (5.6 mmol/L). When fasting blood glucose is between 100 to 125 mg/dL (5.6 to 6.9 mmol/L), changes in lifestyle and monitoring glycemia are recommended, Change from baseline, to one month|Glycated Hemoglobin (HbAlc), A normal A1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes and a level of 6.5% or more indicates diabetes., Change from baseline, to one month | Secondary: Vitamin B6, The reference range for pyridoxal phosphate (PLP), the biologically active form of vitamin B6, is 5-50 µg/L., Change from baseline, to one month|Fasting plasma insulin (F.P.I.)., The insulin fasting blood test is chiefly used to test insulin levels and diagnose diabetes and insulin resistance., Change from baseline, to one month|Insulin resistance (HOMA-IR)., Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance., Change from baseline, to one month|Indoleamine 2,3 dioxygenase (IDO), Has the potential role of indoleamine 2,3 dioxygenase (IDO) as a predictive and therapeutic target for diabetes treatment, Change from baseline, to one month
Sponsor/Collaborators: Sponsor: Al-Rasheed University College
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 108
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-01
Completion Date: 2023-04-01
Results First Posted:
Last Update Posted: 2023-06-26
Locations: Maysan Centre for Diabetes and Endocrinology, Maysan Governorate, 383421, Iraq
URL: https://clinicaltrials.gov/show/NCT05918068