PreDiabetes Clinical Trial
Official title:
Effect of Glucagon on Fasting Insulin Secretion and Glucose Metabolism in Subjects Without Type 2 Diabetes
Fasting hyperglycemia contributes disproportionately to nonenzymatic glycosylation and the microvascular complications of type 2 diabetes. However, little is known about the regulation of glucose concentrations in the fasting state relative to what is known about the postprandial state. The proposed experiment is part of a series of experiments designed to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 1, 2027 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | Inclusion Criteria: - Individuals with normal or impaired fasting glucose and normal or impaired glucose tolerance Exclusion Criteria: - HbA1c less than 6.5% - Use of any glucose-lowering agents including metformin or sulfonylureas. - For female subjects: positive pregnancy test at the time of enrollment or study - History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. - Active systemic illness or malignancy. - Symptomatic macrovascular or microvascular disease. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in beta-cell responsivity induced by glucagon | The beta-cell responsivity observed during glucagon infusion will be compared to that observed during glucose infusion | Beta-cell responsivity will be calculated as the gradient of the relationship between glucose concentrations and insulin secretion rate during the study day over the 4 hours (0 to 240 minutes) of the study | |
Secondary | change in endogenous glucose production induced by glucagon | The endogenous glucose production observed during glucagon infusion will be compared to that observed during glucose infusion | The rate of endogenous glucose production at the end of the study (240 minutes) will be expressed as a percentage of that at the beginning of the study (0 minutes). The % change for each study day will then be compared | |
Secondary | change in glucose disappearance induced by glucagon | The glucose disappearance observed during glucagon infusion will be compared to that observed during glucose infusion | The rate of glucose disappearance at the end of the study (240 minutes) will be expressed as a percentage of that at the beginning of the study (0 minutes). The % change for each study day will then be compared |
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