Status:
COMPLETED
Role of the Liver in Glucose Homeostasis Using Metabolic Imaging
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Type 1 Diabetes
Bariatric Surgery Candidate
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to assess hepatic glucose uptake using non-invasive metabolic imaging in three different populations that differ in terms of insulin and glucose kinetics. Betwee...
Detailed Description
The liver has a central role in maintaining glucose homeostasis. During periods following food intake the liver stores glucose whilst during fasting periods it produces and releases glucose into the c...
Eligibility Criteria
Inclusion
- Age≥18 years
- Capacity to give informed consent
- Willingness to adhere to the study protocol
- In group II (type 1 diabetes), the following criteria must be met in addition:
- T1D for ≥2 years or evidence of undetectable C-peptide (\<100pmol/l with concomitant plasma glucose≥4.0mmol/l)
- HbA1c≤8.0mmol/l (64mmol/mol)
- In group III (bariatric surgery), the following criteria must be met in addition:
- Female
- Bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) ≥1 year ago
- Lack of a history of diabetes or pre-diabetes (HbA1c≤5.6% in the absence of anaemia)
Exclusion
- Pregnancy, planned pregnancy or breastfeeding
- Medication that interfere with glucose metabolism (participation requires discontinuation of these agents at least one week before the study visit) except for individuals with type 1 diabetes
- History of gastrointestinal surgery (other than bariatric surgery for group III)
- Known kidney, liver or heart disease
- Claustrophobia
- Contraindications to magnetic resonance imaging according to designated questionnaire
- Substance abuse
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
Key Trial Info
Start Date :
April 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04352738
Start Date
April 15 2021
End Date
August 30 2022
Last Update
November 15 2022
Active Locations (1)
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1
Inselspital, Bern University Hospital and University Hospital of Bern
Bern, Switzerland, 3010