The Effect of Metformin Accompanied by Insulin on Type I Diabetes in Adolescents

Phase 3

Completed

• Conditions: Diabetes type I; Diabetes, Metformin, Insulin

• Registration Number: TCTR20200701001
• Lead Sponsor: Shahid BeheshtiUniversity of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-12
• Study Start: 2020-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The factors including age 10 to 20 years, diabetes infliction for more than a year, manifestation of diabetic ketoacidosis, the lack of history of diabetes in the family, treatment with multiple daily insulin injections from at least one year ago, receiving of instruction on how to control diabetes at the Children's Endocrine Clinic at least a year ago, the dose of insulin more than one unit per kilogram of body weight, and hemoglobin A1C levels more than 8% over the past six months were considered as inappropriate control criteria for entry into the study.

Exclusion Criteria

The excluding criteria were nephropathy (excretion of more than 200 g of albumin per minute), incidence of diabetic ketoacidosis more than twice a year, proliferative retinopathy, current insulin therapy by conventional method, times of incidence per year, severe and recurrent hypoglycemia, along with decreased level of consciousness, having more than two seizures over the past year (liver or kidney dysfunction, concomitant serious illness, and eating disorders).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HBA1C 4 points: Before and after intervention every 3 months Blood sampling

Secondary Outcome Measures

Name	Time	Method
Insulin 4 points: Before and after intervention every 3 months Sampling