NCT05499702 · Adrian Vella
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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
DRUG
Hyperglycemic clamp
Hyperglycemic clamp to measure the effect of glucagon on hepatic metabolism
Primary outcome measures
Rate of leucine oxidation in response to rising glucagon concentrations
Time frame: 240 minutes of study
tracer-determined amino acid catabolism
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
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Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations