A Study Of Insulin Action On Glucagon Response To Amino Acid Infusion
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-009088
About this study
The purpose of this study is to determine the effect of insulin on Amino Acid (AA)-stimulated glucagon secretion and AA clearance.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Group 1: Obese + Impaired Fasting Glucose (Obese + IFG)
Inclusion Criteria:
Age 25–70 years, inclusive.
BMI ≥28.0 and <40.0 kg/m².
Fasting plasma glucose ≥100 and <126 mg/dL, consistent with impaired fasting glucose (IFG).
HbA1c <6.5%.
No current use of glucose-lowering medications.
Willing and able to comply with all study procedures.
Residence within a 100-mile radius of Mayo Clinic, Rochester, Minnesota.
Eligible for age and sex matching with participants in the comparison groups, as applicable.
Exclusion Criteria:
Age <25 or >70 years.
BMI <28.0 or ≥40.0 kg/m².
Fasting plasma glucose <100 or ≥126 mg/dL.
HbA1c ≥6.5%.
Current use of any glucose-lowering medication.
Pregnancy or a positive pregnancy test at enrollment, if female.
History of major upper abdominal surgery that could affect gastrointestinal or pancreatic physiology, including adjustable gastric banding, pyloroplasty, or vagotomy.
Active systemic illness or malignancy that, in the investigator's judgment, could interfere with study participation or study outcomes.
Symptomatic macrovascular or microvascular disease that, in the investigator's judgment, could interfere with study participation or study outcomes.
Group 2: Lean Control (Lean)
Inclusion Criteria:
Age 25–70 years, inclusive.
BMI ≥19.0 and <25.0 kg/m².
Fasting plasma glucose <100 mg/dL.
HbA1c <5.8%.
No current use of glucose-lowering medications.
Willing and able to comply with all study procedures.
Residence within a 100-mile radius of Mayo Clinic, Rochester, Minnesota.
Age- and sex-matched, as applicable, to participants in the Obese + IFG group.
Exclusion Criteria:
Age <25 or >70 years.
BMI <19.0 or ≥25.0 kg/m².
Fasting plasma glucose ≥100 mg/dL.
HbA1c ≥5.8%.
Current use of any glucose-lowering medication.
Pregnancy or a positive pregnancy test at enrollment, if female.
History of major upper abdominal surgery that could affect gastrointestinal or pancreatic physiology, including adjustable gastric banding, pyloroplasty, or vagotomy.
Active systemic illness or malignancy that, in the investigator's judgment, could interfere with study participation or study outcomes.
Symptomatic macrovascular or microvascular disease that, in the investigator's judgment, could interfere with study participation or study outcomes.
Group 3: Type 1 Diabetes Mellitus (T1DM)
Inclusion Criteria:
Age 25–70 years, inclusive.
BMI ≥28.0 and <40.0 kg/m².
Established diagnosis of type 1 diabetes mellitus (T1DM).
HbA1c ≥5.8% and ≤9.0%.
Current treatment with insulin.
Willing and able to comply with all study procedures.
Residence within a 100-mile radius of Mayo Clinic, Rochester, Minnesota.
Age-, sex-, and BMI-matched, as applicable, to participants in the Obese + IFG group.
Exclusion Criteria:
Age <25 or >70 years.
BMI <28.0 or ≥40.0 kg/m².
HbA1c <5.8% or >9.0%.
Use of glucose-lowering medications other than insulin.
Pregnancy or a positive pregnancy test at enrollment, if female.
History of major upper abdominal surgery that could affect gastrointestinal or pancreatic physiology, including adjustable gastric banding, pyloroplasty, or vagotomy.
Active systemic illness or malignancy that, in the investigator's judgment, could interfere with study participation or study outcomes.
Symptomatic macrovascular or microvascular disease that, in the investigator's judgment, could interfere with study participation or study outcomes.
Group 4: Obese + Normal Fasting Glucose (Obese + NFG)
Inclusion Criteria:
Age 25–70 years, inclusive.
BMI ≥28.0 and <40.0 kg/m².
Fasting plasma glucose <100 mg/dL, consistent with normal fasting glucose (NFG).
HbA1c <5.8%.
No current use of glucose-lowering medications.
Willing and able to comply with all study procedures.
Residence within a 100-mile radius of Mayo Clinic, Rochester, Minnesota.
Age- and sex-matched, as applicable, to participants in the Obese + IFG group.
Exclusion Criteria:
Age <25 or >70 years.
BMI <28.0 or ≥40.0 kg/m².
Fasting plasma glucose ≥100 mg/dL.
HbA1c ≥5.8%.
Current use of any glucose-lowering medication.
Pregnancy or a positive pregnancy test at enrollment, if female.
History of major upper abdominal surgery that could affect gastrointestinal or pancreatic physiology, including adjustable gastric banding, pyloroplasty, or vagotomy.
Active systemic illness or malignancy that, in the investigator's judgment, could interfere with study participation or study outcomes.
Symptomatic macrovascular or microvascular disease that, in the investigator's judgment, could interfere with study participation or study outcomes.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 08/10/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Adrian Vella, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available