Effect of thiamine and magnesium sulfate in treatment of diabetes

Phase 2

• Conditions: Diabetes-Insulin resistance.; Type 2 diabetes mellitus with hyperosmolarity with coma; E11.01

• Registration Number: IRCT20151028024756N4
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with a definitive diagnosis of type 2 diabetes for more than 5 years by a physician (plasma glucose level greater than 126 mg/dL and HbA1c between 6.5 and 8 percent at least 3 months before the start of the study)
Men or women in the age range is over 18 years with a body mass index of 18.5 to 30 kg/m2 . 3
Patients taking metformin
Being able to communicate and volunteer to participate in the research.
Signature written consent
Residence in Isfahan city
The possibility of continuous monitoring of patients.

Exclusion Criteria

Pregnancy and breastfeeding
Smoking and alcohol consumption during study and in the last year
Suffering from other underlying diseases such as severe liver failure, kidney failure (serum creatinine more than 4 mg/dL), severe cardiovascular diseases, stroke up to 3 months before the start of the research, cancer, inflammatory diseases, severe infection, and thyroid disorders.
Taking drugs such as insulin, immunosuppressive drugs, anti-inflammatories.
Taking medicinal supplements containing magnesium, thiamine or a history of allergy to these drugs.
Patients with severe ketosis.
Change in the type or dose of diabetes medication during the intervention.
Patients with poor and inappropriate nutrition and with persistent anemia (hemoglobin less than 6 mg/dL).
Patients who consume less than 90% of the tested medication will be excluded from the study
Traveling for more than two weeks

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose-. Timepoint: Before intervention and every 3 months. Method of measurement: By using kit and according to the kit instructions.;HbA1c. Timepoint: Before intervention and every 3 months. Method of measurement: By using kit and according to the kit instructions.

Secondary Outcome Measures

Name	Time	Method
HOMA-IR. Timepoint: Before intervention and every three months. Method of measurement: By using specific kits.;GLUT4 gene expression. Timepoint: Before intervention and every three months. Method of measurement: By using specific kit.;FOXO1 gene expressions. Timepoint: Before intervention and every three months. Method of measurement: By using specific kit.