Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion (NCT05264727) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
United States30 participantsStarted 2023-05-30
Plain-language summary
This study is being done to better understand how amino acids alter the release of glucagon and insulin compared to glucose alone in health and disease.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria - Obese Subjects with Type 2 Diabetes:
* HbA1c ≤ 8.5% (type 2 diabetic subjects).
* HbA1c ≤ 6.5% (obese and lean subjects).
* BMI ≥ 28 Kg/M\^2 (Obese subjects with and without type 2 diabetes).
* BMI ≤ 25 Kg/M\^2 (Lean subjects without type 2 diabetes).
* Use of sulfonylureas or metformin only (type 2 diabetec subjects).
* For female subjects: negative pregnancy test at the time of enrollment or study.
* No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* No active systemic illness or malignancy.
* No symptomatic macrovascular or microvascular disease.
* No 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 negative AUDIT questionnaire.
Exclusion Criteria - Obese Subjects with Type 2 Diabetes:
* HbA1c ³ 8.5%
* BMI ≤ 28 Kg/M2
* Use of insulin or agents other than sulfonylureas or metformin.
* 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.
* 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.
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Glucagon Suppression (G50) caused by amino acids vs. saline