Type 2 Diabetes Mellitus. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: The intervention involves the consumption of the NBS dietary supplement along with continuous oral support to address nutritional challenges for a duration of 6 mon
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 years BMI = 25 kg/m² Glycated Hemoglobin (HbA1c) = 6.5% Fasting Blood Glucose Levels = 126 mg/dL Treated with Metformin prior to enrollment in the study
Exclusion criteria
Exclusion criteria: Withdrawal from the study by the participant. Presence of inflammatory diseases. Chronic kidney or liver diseases (Chronic Kidney Disease (CKD) defined as kidney damage or an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² persisting for = 3 months, leading to gradual loss of kidney function and often requiring renal replacement therapy such as dialysis or kidney transplantation. Acute liver failure is defined as severe acute liver injury lasting less than 26 weeks, accompanied by encephalopathy and INR = 1.5 in the absence of prior cirrhosis or liver disease.) Patients undergoing hormone replacement therapy or taking antioxidant supplements. Patients treated with insulin. Patients unable to attend scheduled follow-up visits. Pregnant or lactating women. Drug hypersensitivity detected by the physician. Clinical deterioration due to NBS powder as determined by the physician. Diagnosis of Type 1 Diabetes. History of pancreatitis. Proliferative diabetic retinopathy or non-proliferative retinopathy requiring acute treatment. Proliferative Diabetic Retinopathy Diabetic maculopathy. Hepatitis. Gastroparesis. Estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73 m² for patients on metformin. Use of any anti-hyperglycemic drugs within 3 months prior to screening. Use of lipid-lowering medications such as atorvastatin. Non-compliance with prescribed therapeutic and medication regimens. Occurrence of serious or unexpected adverse effects during the study. Emergence of new or widespread medical conditions that may impact study outcomes. Withdrawal from the study due to personal reasons or inability to continue participation. Transfer to other studies or initiation of alternative therapies requiring study discontinuation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C Levels. Timepoint: Before the Intervention and 6 Months After the Intervention. Method of measurement: Enzymatic Assay.;Blood Glucose Levels. Timepoint: Before the Intervention and 6 Months After the Intervention. Method of measurement: Autoanalyzer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid Profile, Including Total Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglyceride. Timepoint: Before the Intervention and 6 Months After the Intervention. Method of measurement: Autoanalyzer.;Creatinine and Blood Urea Nitrogen Levels. Timepoint: Before the Intervention and 6 Months After the Intervention. Method of measurement: Autoanalyzer.;Insulin resistance factors, HOMA-IR and HOMA-DR. Timepoint: Before the Intervention and 6 Months After the Intervention. Method of measurement: ELISA kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehrdad Mosadegh
Tehran University of Medical Sciences
Outcome results
None listed