Does Metformin improve vascular function in youth with Type 1 diabetes

Phase 4

Recruiting

• Conditions: Type 1 diabetes; Obesity; Vascular health; Metabolic and Endocrine - Diabetes; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Diet and Nutrition - Obesity

• Registration Number: ACTRN12611000148976
• Lead Sponsor: Alexia Pena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Body Mass Index > 50th centile for age Type 1 Diabetes duration greater than 1 year and insulin requirements > 0.5 units/kg/day
Baseline comparator group: Body Mass Index > 50th centile for age

Exclusion Criteria

non type 1 diabetes Severe hypoglycaemic episode in the previous 6 months Recurrent Diabetic ketoacidosis (> 2 episode in the previous year) History of smoking OR serum cotinine level > 28 nmol/L Other serious comorbidities (eg liver and renal disease) Contraindications to metformin therapy (hypersensitivity, renal or liver dysfunction, Vitamin B12 deficiency) Inability to abstain from alcohol Pregnancy or breastfeeding Subjects already taking metformin, oral contraceptives, antihypertensives, multivitamins or statins

Baseline comparator group: type 1 diabetes or non type 1 diabetes History of smoking OR serum cotinine level > 28 nmol/L Other serious comorbidities (eg liver and renal disease) Pregnancy or breastfeeding Subjects already taking metformin, oral contraceptives, antihypertensives, multivitamins or statins

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular function (flow mediated dilatation and Glyceryl trinitrate induced dilatation)[0, 3, 6, 12 months]

Secondary Outcome Measures

Name	Time	Method
serum adiponectin/leptin ratio[0, 3, 6, 12];Waist circumference[0, 3, 6, 12 months];Body mass index[0, 3, 6, 12 months];Body composition assessed by DEXA (nuclear medicine study)[0, 12 months];Insulin requirements - calculated from total daily dose of insulin[0, 3, 6, 12 months];whole blood HbA1c[0, 3, 6, 12 months];Fasting serum Lipids[0, 3, 6, 12 months];serum HsCRP[0, 3, 6, 12 months];Retinal photograph[0, 12 months]