The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Adrian Vella
Study ID
NCT05499702
Phase
PHASE2
Status
Recruiting
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Conditions

  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Caloric Restriction — BEHAVIORAL
    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 — DRUG
    Hyperglycemic clamp to measure the effect of glucagon on hepatic metabolism

Study Details

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.

Key Dates

Start date
Dec 15, 2022
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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