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Does Metformin improve vascular function in youth with Type 1 diabetes

Does Metformin improve vascular function in youth with Type 1 Diabetes

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000148976
Enrollment
76
Registered
2011-02-08
Start date
2011-02-09
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Cardiovascular disease is the leading cause of mortality in type 1 diabetes (T1D). Prevention of vascular complications of diabetes requires strategies that begin early in the disease process. Risk factors in childhood track into adulthood and correlate with early markers of atherosclerosis such as vascular endothelial and smooth muscle function. We have shown that children and adolescents with type 1 diabetes have detectable endothelial and smooth muscle dysfunction that relate to body mass index (BMI). A significant number of youth with T1D are also overweight with insulin resistance. Metformin reduces insulin requirements and weight gain in type 1 diabetes. In type 2 diabetes Metformin substantially reduces risk of cardiovascular events and improves endothelial function. However there are no studies of cardiovascular outcomes or their earlier cardiovascular markers in type 1 diabetes despite the increasing prevalence of overweight status in this population and the fact that this is a major modifiable risk factor for cardiovascular disease. Determining the effect of Metformin on vascular function in overweight youth with type 1 diabetes in a double blind randomized placebo controlled parallel trial will provide additional strategies to intervene in early in the process of atherosclerosis.

Interventions

Administration of Metformin tablets: If weight > 60kg - 500mg daily for 2 weeks increased to 1g twice daily over the following 6 weeks, then 1g twice daily for 12 months. For weight < 60kg - 500mg daily for 2 weeks then 500mg twice daily for 6 months. Dietary advice - session with a dietician (1 hour) at the commencement of the study and a review at 3 months (1 hour) a written information sheet will be provided. Activity data will be collected prior each dietary assessment using a SensWear devic

Administration of Metformin tablets: If weight > 60kg - 500mg daily for 2 weeks increased to 1g twice daily over the following 6 weeks, then 1g twice daily for 12 months. For weight < 60kg - 500mg daily for 2 weeks then 500mg twice daily for 6 months. Dietary advice - session with a dietician (1 hour) at the commencement of the study and a review at 3 months (1 hour) a written information sheet will be provided. Activity data will be collected prior each dietary assessment using a SensWear device (external device worn over the upper arm - like a watch) for 5 days.

Sponsors

Alexia Pena
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 23, 2026