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The Effects of Glucagon on Hepatic Metabolism

A

Adrian Vella

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Type2diabetes
Obesity
NAFLD

Treatments

Drug: Glucagon response study

Study type

Interventional

Funder types

Other

Identifiers

NCT05500586
22-000113

Details and patient eligibility

About

Whether impaired postprandial glucagon suppression in prediabetes and T2DM is an attempt to overcome resistance to glucagon's actions on hepatic AA catabolism, a defect in α-cell function, or a combination of both are important, unanswered questions. NAFLD is associated with T2DM risk and impaired insulin action. Unfortunately, it is unclear if glucagon resistance is caused by obesity, hepatic steatosis or both. The experiments outlined will determine if glucagon's actions on hepatic amino acid catabolism and EGP interact with hepatic lipid metabolism in lean and obese subjects with and without T2DM (and with varying degrees of hepatic steatosis).

Full description

T2DM and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing EGP. Although these effects are magnified by decreased and delayed insulin secretion, they are also apparent when insulin secretion is intact. In rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating AA concentrations. Are the elevated concentrations of branched-chain AA and other AA metabolites in T2DM a cause or an effect of global α-cell dysfunction? Could altered glucagon signaling precipitate a vicious cycle resulting in T2DM?

Enrollment

60 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Willing to participate
  • Able to give consent

Exclusion criteria

  • History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.
  • Contraindications to MRI (e.g. metal implants, claustrophobia).
  • Hematocrit < 35%
  • TSH < 0.4 or > 5.5.
  • Consumption of > 2 alcohol drinks per day or > 14 per week or a positive AUDIT questionnaire

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Healthy Adults
Experimental group
Description:
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Treatment:
Drug: Glucagon response study
Obese Adults
Experimental group
Description:
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Treatment:
Drug: Glucagon response study
Adults with Type 2 Diabetes
Experimental group
Description:
We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.
Treatment:
Drug: Glucagon response study

Trial contacts and locations

1

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Central trial contact

Jeanette Laugen

Data sourced from clinicaltrials.gov

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