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Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes (IMPACT-1D)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511867-27-00
Acronym
D20180102
Enrollment
230
Registered
2024-09-10
Start date
2021-06-02
Completion date
Unknown
Last updated
2024-09-10

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

Conditions

Vascular calcification and type 1 diabetes

Brief summary

Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.

Detailed description

Difference between below-knee arterial ultrasonographic occlusion score at T0 and T2years in type 1 diabetic patients supplemented or not with metformin., Difference between ankle and toe brachial indexes at T0 and T2years in type 1 diabetic patients supplemented or not with metformin., Difference between pulse wave velocity at T0 and T2 years in type 1 diabetic patients supplemented or not with metformin., Difference between coronary calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin., Difference between below-knee arterial calcification score progression between T0 and T2years in type 1 diabetic patients treated or not with metformin and with initial below-knee arterial calcification score ≤ and >400.

Interventions

DRUGMETFORMINE ARROW LAB 1000 mg
DRUGPlacebo de metformine Arrow Lab 1000 mg - Composition: Cellulose microcristalline; Lactose monohydraté; Stéarate de magnésium (vegetable origin); Opadry TM 07F28588; Eau purifiée

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.

Secondary

MeasureTime frame
Difference between below-knee arterial ultrasonographic occlusion score at T0 and T2years in type 1 diabetic patients supplemented or not with metformin., Difference between ankle and toe brachial indexes at T0 and T2years in type 1 diabetic patients supplemented or not with metformin., Difference between pulse wave velocity at T0 and T2 years in type 1 diabetic patients supplemented or not with metformin., Difference between coronary calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin., Difference between below-knee arterial calcification score progression between T0 and T2years in type 1 diabetic patients treated or not with metformin and with initial below-knee arterial calcification score ≤ and >400.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026