The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
Recruiting · NCT05499702 · Interventional (participants receive a specific treatment) · Lead sponsor: Adrian Vella
View the official record on ClinicalTrials.gov →Interventions studied
Caloric RestrictionHyperglycemic clamp
What this trial 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. 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.
Who can take part
Age range
25 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States