Glucagon Resistance in Patients With NAFLD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-05

Study Completion Date

2022-08-18

Brief Summary

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The investigators propose that the sensitivity to glucagon in hepatic lipid metabolism is impaired in subjects with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH). Moreover, they propose a dys-coordinated, reduced glucagon sensitivity in hepatic lipid metabolism and endogen glucose production in patients with NAFLD and NASH compared with healthy subjects and patients with simple steatosis. This reduced sensitivity may be the basis of a more severe dyslipidemia and the production of increased concentrations of toxic lipid intermediates in plasma and muscle tissue. The study will include healthy subjects with obesity and subjects with simple steatosis and NASH, tested at basal glucagonemia and moderate hyperglucagonemia to mimic insulin resistant levels during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers in combination with indirect calorimetry as well as skeletal and adipose tissue biopsies will be employed to assess free fatty acid and VLDL-triglyceride kinetics (turnover, and oxidation) and hepatic fatty acid-esterification.

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Detailed Description

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Conditions

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Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Glucose Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy overweight subjects

MR spectroscopy verified no steatosis

Group Type ACTIVE_COMPARATOR

glucagon

Intervention Type OTHER

Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.

Subjects with non-alcoholic fatty liver disease

MR spectroscopy verified steatosis, no steatohepatitis on liver biopsy

Group Type ACTIVE_COMPARATOR

glucagon

Intervention Type OTHER

Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.

Subjects with non-alcoholic steatohepatitis

MR spectroscopy verified steatosis, steatohepatitis on liver biopsy

Group Type ACTIVE_COMPARATOR

glucagon

Intervention Type OTHER

Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.

Interventions

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glucagon

Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI \> 28 kg/m2
* steatosis FF% \> 5,6% on MR spectroscopy for NAFLD and NASH groups

Exclusion Criteria

* active smoking
* pregnancy
* comorbidity other than hypertension and hyperlipidemia
* participation in other radioactive isotope studies within the past 3-5 months (depending on radiation dose)
* blood donation (within 3 months)

Minimum Eligible Age

38 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes