Understanding insulin and glucagon interactions during fasting in prediabetes
Effect of Insulin and Insulin Pulses on Fasting Glucagon Secretion and on Glucose Metabolism in Subjects Without Type 2 Diabetes
This study is testing how insulin and glucagon work together to control blood sugar levels during fasting in people with prediabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06424015 on ClinicalTrials.gov |
What this trial studies
This study investigates how insulin and glucagon interact to regulate fasting glucose levels in individuals with prediabetes. It aims to explore the effects of insulin signaling on glucagon secretion and how these hormones influence glucose production in the liver. By examining the relationship between insulin and glucagon during fasting, the study seeks to identify potential markers of β-cell health and the dynamics of hormone crosstalk. The interventions include administering intralipid and heparin to assess their impact on hormone secretion.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with normal or impaired fasting glucose and normal or impaired glucose tolerance.
Not a fit: Patients with HbA1c greater than 6.5%, severe obesity, or those on glucose-lowering medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of fasting glucose levels in prediabetes, potentially preventing the progression to type 2 diabetes.
How similar studies have performed: While there is ongoing research into insulin and glucagon interactions, this specific approach to studying fasting glucose regulation in prediabetes is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * people with normal or impaired fasting glucose and normal or impaired glucose tolerance Exclusion Criteria: 1. HbA1c \> 6.5% 2. BMI ≥ 35 Kg/M2 3. Use of any glucose-lowering agents including metformin or sulfonylureas. 4. For female subjects: positive pregnancy test at the time of enrollment or study 5. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. 6. Active systemic illness or malignancy. 7. Symptomatic macrovascular or microvascular disease. 8. Hematocrit \< 35%
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Adrian Vella, MD — Mayo Clinic
- Study coordinator: Kim Osmundson, CCRP
- Email: Osmundson.Kimberly@mayo.edu
- Phone: 507-255-0907
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.