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Role of the Liver in Glucose Homeostasis Using Metabolic Imaging (LEMON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352738
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Lia Bally, University Hospital Inselspital, Berne

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. Between-group comparison will address the following two hypotheses:

i) Hepatic glucose uptake will be lower in participants with type 1 diabetes compared with matched controls due to lack of portal insulin and delayed pharmacokinetics of subcutaneous bolus insulin.

ii) Hepatic glucose uptake will be higher in participants after bariatric surgery compared with matched health controls due to accelerated glucose absorption and earlier and higher peak portal glucose and insulin concentrations.


Condition or disease Intervention/treatment
Type 1 Diabetes Bariatric Surgery Candidate Diagnostic Test: Multiparametric, multinuclear MR (DMI/ 13C-MRS/ GlycoCEST/GlycoNOE)

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Deciphering the Role of the Liver in Glucose Homeostasis Using Metabolic Imaging
Actual Study Start Date : April 15, 2021
Actual Primary Completion Date : April 21, 2022
Actual Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Healthy adults (group I) Diagnostic Test: Multiparametric, multinuclear MR (DMI/ 13C-MRS/ GlycoCEST/GlycoNOE)
Magnetic resonance scanning for 150 minutes involving ingestion of 60g of 6,6, 2H2-glucose diluted in 200ml of tap water. Frequent blood samples will be drawn for measurements of plasma glucose, insulin, C-peptide and glucagon

Adults with type 1 diabetes (group II)
  • 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).
Diagnostic Test: Multiparametric, multinuclear MR (DMI/ 13C-MRS/ GlycoCEST/GlycoNOE)
Magnetic resonance scanning for 150 minutes involving ingestion of 60g of 6,6, 2H2-glucose diluted in 200ml of tap water. Frequent blood samples will be drawn for measurements of plasma glucose, insulin, C-peptide and glucagon

Adults after bariatric surgery (group III)
  • 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).
Diagnostic Test: Multiparametric, multinuclear MR (DMI/ 13C-MRS/ GlycoCEST/GlycoNOE)
Magnetic resonance scanning for 150 minutes involving ingestion of 60g of 6,6, 2H2-glucose diluted in 200ml of tap water. Frequent blood samples will be drawn for measurements of plasma glucose, insulin, C-peptide and glucagon




Primary Outcome Measures :
  1. Intrahepatic free glucose concentration [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]

Secondary Outcome Measures :
  1. Postprandial hepatic glycogen increment [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
  2. Postprandial glucose exposure [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
    Incremental area under the glucose concentration curve

  3. Postprandial glucagon exposure [ Time Frame: Over postprandial period (0 to150 minutes post glucose-ingestion) ]
    Incremental area under the glucagon concentration curve

  4. Postprandial insulin secretion [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
    Calculated using the Oral Glucose minimal Model

  5. Postprandial insulin exposure [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
    Incremental area under the insulin concentration curve

  6. Postprandial insulin clearance [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
  7. Postprandial whole body insulin sensitivity [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
    Calculated using the Oral Glucose Minimal Model

  8. Postprandial hepatic glucose production [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
    Estimated using the single tracer oral minimal model based on the ingested dose of 6,6-2H2-glucose and plasma 6,6-2H2-glucose enrichment

  9. First-pass hepatic extraction of glucose [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]

Other Outcome Measures:
  1. Quantification of 2H-labelled metabolites other than glucose (i.e. lactate, glutamate/glutamine, water) [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]
  2. Changes in intrahepatocellular lipid (IHCL) [ Time Frame: Over postprandial period (0 to 150 minutes post glucose-ingestion) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy participants will be recruited through advertisement on the hospital staff website and website of the Medical faculty according to Swissethics guidelines. Patients with type 1 diabetes and post-bariatric surgery patients will be recruited through referring physicians from the University Hospital Bern or colleagues from local private outpatient clinics.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352738


Locations
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Switzerland
Inselspital, Bern University Hospital and University Hospital of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lia Bally, MD, PhD University Hospital Bern & University of Bern
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Responsible Party: Lia Bally, Professor, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04352738    
Other Study ID Numbers: LEMON
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lia Bally, University Hospital Inselspital, Berne:
Hepatic glucose metabolism
Deuterium metabolic imaging
Insulin and glucose kinetics
Metabolic imaging
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases