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Insulin resistance in type 1 diabetes managed with metformin (INTIMET): Study protocol of a double-blind placebo-controlled, randomised trial.

Healthy Ageing, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia. St Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia. Department of Diabetes and Endocrinology, St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia. Department of Diabetes and Endocrinology, Westmead Hospital, Westmead, NSW, Australia. Stats Central, University of New South Wales, Sydney, NSW, Australia. Mark Wainwright Analytical Centre, University of New South Wales, Sydney, NSW, Australia. Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Vic., Australia. Westmead Clinical School, Sydney Medical School, The University of Sydney, Westmead, NSW, Australia.

Diabetic medicine : a journal of the British Diabetic Association. 2021;(9):e14564
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Abstract

BACKGROUND Insulin resistance is an under-recognised metabolic defect and cardiovascular risk factor in Type 1 diabetes. Whether metformin improves hepatic, muscle or adipose tissue insulin sensitivity has not been studied in adults with Type 1 diabetes. We initiated the INTIMET study (INsulin resistance in Type 1 diabetes managed with METformin), a double-blind randomised, placebo-controlled trial to measure the effect of metformin on tissue-specific insulin resistance in adults with Type 1 diabetes. METHODS We will study 40 adults aged 20-55 years with Type 1 diabetes (HbA1c ≤ 80 mmol/mol [9.5%], fasting C-peptide <0.3 nmol/L) and 20 age-, gender- and body mass index (BMI)-matched controls. Insulin sensitivity will be determined by the two-step hyperinsulinaemic-euglycaemic clamp method with deuterated glucose to document liver, muscle and adipose insulin sensitivity. Subjects with Type 1 diabetes will be randomised to metformin extended-release 1500 mg daily or matched placebo for 26 weeks. The primary outcome is change in hepatic insulin sensitivity, assessed by change in basal rate of appearance (Ra) of glucose and suppression of endogenous glucose production (EGP) during the low-dose stage of the clamp. CONCLUSION The INTIMET study is the first clinical trial to quantify the impact of metformin on liver, muscle and adipose insulin resistance in adults with Type 1 diabetes. This study may identify factors that predict an individual's response to metformin in Type 1 diabetes. TRIAL REGISTRATION ACTRN12619001440112.

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