Status:
COMPLETED
Liver and Metabolic Effects of Insulin Pump Therapy in Diabetics Type 2 with Non-alcoholic Hepatic Steatosis
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
University Hospital, Angers
Conditions:
Type 2 Diabetes (T2D)
Eligibility:
All Genders
37-70 years
Phase:
NA
Brief Summary
The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). N...
Eligibility Criteria
Inclusion
- Male / female 35/70 years (including ranges) with T2D ≥ 1 year
- Benefiting from the indication of use of the free Freestyle glucose meter
- Treatment with multi-injection insulin therapy comprising a daily injection of basal insulin (Glargine U100, Glargine U300, Degludec) and at least 2 daily injections of an insulin analogue (lispro, aspart or glulisine) +/- metformin, dipeptidyl peptidase-4 (DPP4) and/or sodium-glucose cotransporter type 2 (SGLT2) at a dose stable for at least 3 months.
- For women of childbearing age, oestro-progestative pill, IUD, implant.
- 11% ≥ HbA1c ≥ 6.5%
- Presence of hepatic steatosis according to the ultrasonography
- Absence of chronic alcoholic intoxication
- Absence of chronic viral hepatitis or other chronic liver diseases (eg hemochromatosis ...)
Exclusion
- Type 1 diabetes
- Contraindication to pump treatment
- Treatment with anti-diabetics or other than metformin, dipeptidyl peptidase-4 (DPP4) and/or sodium-glucose cotransporter type 2 (SGLT2)
- Treatment with basal inulin of Levemir
- Contraindication to performing MRI
- Chronic alcohol abuse (after alcohol consumption\> 20g / day in men and\> 10g / day in women) according to the medical examination
- Chronic viral hepatitis based on HBV and HCV serology results
- Hemochromatosis according to the martial assessment
- Other toxic or drug hepatitis
- Severe hepatic pathology: hepatic cirrhosis, hepatocellular carcinoma
- Severe renal insufficiency (MDRD \<30 ml / min)
- Severe and progressive cardiovascular pathology
- Treatment (permanent or intermittent) with glucocorticoids
- Treatment known to improve hepatic steatosis (glitazone, vitamin E, orlistat)
- history or bariatric surgery project for the duration of the study
- Drug treatment likely to cause hepatic steatosis (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retroviral drugs) unless the dose has been stable for ≥ 3 months
- Guardianship, curatorship or safeguard of justice
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04270656
Start Date
February 5 2021
End Date
September 23 2024
Last Update
October 17 2024
Active Locations (9)
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1
CHU
Angers, France, 49933
2
CHU
Caen, France, 14033
3
CHU
Dijon, France, 21000
4
CHU
La Rochette, France, 17019