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Clinical Trials/NCT05500586
NCT05500586
Completed
Phase 1

The Effects of Glucagon on Hepatic Metabolism

Adrian Vella1 site in 1 country21 target enrollmentStarted: October 20, 2022Last updated:

Overview

Phase
Phase 1
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Rate of Amino acid catabolism in the presence / absence of glucagon

Overview

Brief Summary

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).

Detailed 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?

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.
  • Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire

Arms & Interventions

Healthy Adults

Experimental

We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.

Intervention: Glucagon response study (Drug)

Obese Adults

Experimental

We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.

Intervention: Glucagon response study (Drug)

Adults with Type 2 Diabetes

Experimental

We will study 20 subjects on one occasion using a hyperglycemic clamp with 2 doses of glucagon.

Intervention: Glucagon response study (Drug)

Outcomes

Primary Outcomes

Rate of Amino acid catabolism in the presence / absence of glucagon

Time Frame: 240 minutes of study

Tracer-dependent measurement of amino-acid clearance

Secondary Outcomes

  • Effect of Diabetes on amino-acid catabolism(240 minutes of study)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Adrian Vella

Regulatory Sponsor

Mayo Clinic

Study Sites (1)

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