A Phase 4 interventional study of Metformin and Lifestyle recommendations in Coronary Artery Disease, Atherosclerosis and Prediabetic State, sponsored by Pauls Stradins Clinical University Hospital. Completed at 1 site in Latvia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Pauls Stradins Clinical University Hospital · Phase 4, Interventional, and Treatment
Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up.
The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.
Patients undergoing PCI and IVUS pullback for the target vessel will be enrolled in a prospective study. Before PCI and at 24 month follow up fasting blood will be collected for glucose, HbA1c, C peptide, lipid profile assessment. Patients' baseline demographic characteristics, medical history, and procedural data will be collected during the index hospitalization and at 24 month follow up. Patients will be divided in groups according to HbA1c - control group (HbA1c\<5.7) and prediabetic patients (HbA1c 5.7-6.4). PCI will be performed in accordance with the guidelines. After successful treatment of the culprit lesion IVUS will be done. Following PCI and IVUS patients with prediabetes will be randomly assigned in groups either receiving metformin at a dose of 2000 mg once daily plus standard lifestyle recommendations or standard lifestyle recommendations only. Intravascular ultrasound analysis will be repeated 24 months after the initial PCI.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 70 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Pauls Stradins Clinical University Hospital is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Patients with HbA1c 5.7-6.4 receiving metformin and lifestyle recommendations
Drug: Metformin · Behavioral: Lifestyle recommendations
Patients with HbA1c 5.7-6.4 receiving lifestyle recommendations
Behavioral: Lifestyle recommendations
In order to minimize gastrointestinal discomfort, metformin treatment will be started with a dose of 500 mg p/o once daily, then gradually increased to 2000 mg p/o once daily for 24 months
Also known as: Glucophage extended release (XR)
Standard lifestyle recommendations
Percentage plaque volume change over 24 months
Changes in plaque volume in 24 months
Time frame: 24 months
Culprit lesion in-stent restenosis
Neointimal hyperplasia at 24 month follow up
Time frame: 24 months
Plaque tissue component percentage change over 24 months
Percentage change in necrotic, fibrotic, lipidic and calcific tissue volume
Time frame: 24 months
Correlation of glycemic parameters with plaque characteristics
Correlation of glycemic parameters with plaque characteristics
Time frame: At index hospitalization and follow up (24 months)
Plaque volume change in metformin vs non-metformin treated patients over 24 months
Plaque volume change in metformin vs non-metformin treated patients over 24 months
Time frame: 24 months
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Pauls Stradins Clinical University Hospital