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

Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes: a randomized, double-blind clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230930059564N1

Enrollment

Registered

2023-11-20

Start date

2023-12-21

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes. Type 1 diabetes mellitus

Interventions

Intervention 1: Intervention group: receiving 500 mg metformin twice a day for 6 months. Intervention 2: Control group: receiving 500 mg placebo twice a day for 6 months.

Eligibility

Sex/Gender

All

Age

8 Years to 21 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsieh Mosalanejad

Shahid Beheshti University of Medical Sciences

mosalladr@sbmu.ac.ir+98 21 2222 7021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026