Recruiting
Phase 2

Glucagon

Sponsor:

Adrian Vella

Code:

NCT05499702

Conditions

Type2diabetes

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Caloric Restriction

Hyperglycemic clamp

Study Details

Brief summary:

Caloric restriction (and RYGB) improves insulin action and lowers fasting glucose, glucagon and EGP, without changes in postprandial EGP and glucagon concentrations. Caloric restriction also improves hepatic steatosis and lowers fasting AA. These changes may represent restoration of glucagon's hepatic actions. This experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in T2DM in comparison to a baseline experiment performed separately in people with T2DM.

Conditions

Type2diabetes

Study ID

NCT05499702

Start date

Dec 15, 2022

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • We will recruit up to 20 weight-stable, subjects with type 2 diabetes
  • BMI ≥ 28 Kg/M2
  • Diabetes is managed by diet alone or a combination of oral agents

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Adults with type 2 diabetes

20 subjects will be studied on one occasion, following 6 weeks of caloric restriction. They will be instructed to consume a diet of 900 kcal daily using meals derived from "Nutritional Guidelines after Bariatric Surgery". Compliance will be monitored by weekly meetings with the dietician using an electronic record of food intake. After this subjects will undergo a hyperglycemic clamp with 2 doses of glucagon infused.

Interventions

Caloric Restriction

Subjects will be instructed to consume a diet of 900 kcal daily using meals derived from "Nutritional Guidelines after Bariatric Surgery". Compliance will be monitored by weekly meetings with the dietician using an electronic record of food intake

Hyperglycemic clamp

Hyperglycemic clamp to measure the effect of glucagon on hepatic metabolism

Primary outcome measure

  • Rate of leucine oxidation in response to rising glucagon concentrations [ Time Frame: 240 minutes of study ]

Central Contacts and Locations

Central contacts

Jeanette Laugen

5072558110Laugen.Jeanette@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Adrian Vella

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • glucagon
  • insulin resistance
  • caloric restriction
  • hepatic steatosis
  • amino acid metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Adrian Vella on 2026-05-28.