The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restri… (NCT05499702) | Clinical Trial Compass
RecruitingPhase 2
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
United States20 participantsStarted 2022-12-15
Plain-language summary
Caloric restriction (and RYGB) improves insulin action and lowers fasting glucose, glucagon and EGP, without changes in postprandial EGP and glucagon concentrations. Caloric restriction also improves hepatic steatosis and lowers fasting AA. These changes may represent restoration of glucagon's hepatic actions. This experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in T2DM in comparison to a baseline experiment performed separately in people with T2DM.
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:
* 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.
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.
1This trial is studying how glucagon affects liver metabolism in people with type 2 diabetes after a period of caloric restriction — would my current diabetes medications or diet routine interfere with what they're trying to measure, and would I need to change anything before participating?
2Since this is a Phase 2 trial, what do we know so far about the safety of the procedures involved, like the glucagon infusions or the caloric restriction period, for someone in my situation?
3The trial is measuring something called leucine oxidation — can you help me understand what that tells researchers about how glucagon affects my liver, and why that matters for type 2 diabetes treatment?
4Given that this study seems focused on understanding how the body works rather than directly treating my diabetes, would participating in this research actually affect my own diabetes management, or would I still need to continue with my current treatment plan?
5Are there standard treatments or lifestyle changes I should consider first before looking at a research study like this one, or does my situation make this trial worth exploring sooner?
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
Rate of leucine oxidation in response to rising glucagon concentrations