Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes

Phase 4

Recruiting

• Conditions: Type 1 diabetes.; Type 1 diabetes mellitus

• Registration Number: IRCT20230930059564N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Age 8 to 21 years
Body mass index (BMI) percentile for ages 5 to 85
Receiving insulin (Recombinant, NPH, Regular)
Not using metformin in the past year
Diagnosis of type 1 diabetes (at least 5 years)
Not suffering from diabetic ketoacidosis or hypoglycemia (blood sugar level less than 50 mg/dL) in the last 6 months
Not using metformin in the past year
Not taking anti-hypertensive, anti-inflammatory, anti-coagulant, fat-reducing, weight-reducing and antioxidant drugs in the last 6 months
Willingness to participate in the plan

Exclusion Criteria

Pregnant or lactating people
Having severe side effects of metformin (lactic acidosis, severe digestive problems)
Suffering from endocrine disorders such as hypothyroidism
Any acute illness that leads to hospitalization of the patient
Lack of compliance (the patient does not want to continue participating in the study for any reason)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilatation. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Sonography.;Glycated hemoglobin A1C. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Elisa kit.;Triglyceride. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Elisa kit.;Fasting blood sauger. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Elisa kit.;Body mass index. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Calculate weight divided by height (cm) to the power of two.