Effects of glucagon on liver metabolism in people with type 2 diabetes after reducing calorie intake
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
This study is testing how cutting calories affects the way glucagon works in the liver for people with type 2 diabetes to see if it helps improve their blood sugar control.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05499702 on ClinicalTrials.gov |
What this trial studies
This study investigates how caloric restriction influences glucagon's role in liver metabolism among individuals with type 2 diabetes. It aims to understand the relationship between caloric intake, glucagon action, and metabolic parameters such as amino acid, carbohydrate, and lipid metabolism. By comparing the effects of caloric restriction on hepatic glucagon action to baseline measurements, the study seeks to clarify the mechanisms behind improved insulin action and reduced fasting glucose levels. The research will involve interventions like caloric restriction and hyperglycemic clamps to assess metabolic changes.
Who should consider this trial
Good fit: Ideal candidates for this study are weight-stable adults with type 2 diabetes and a BMI of 28 kg/m² or higher, managed by diet or oral medications.
Not a fit: Patients with a history of upper abdominal surgery, active systemic illness, or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for type 2 diabetes through enhanced understanding of glucagon's role in metabolism.
How similar studies have performed: Previous studies have shown that caloric restriction can improve metabolic parameters in type 2 diabetes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Adrian Vella — Mayo Clinic
- Study coordinator: Jeanette Laugen
- Email: Laugen.Jeanette@mayo.edu
- Phone: 5072558110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.