Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy … (NCT06609356) | Clinical Trial Compass
RecruitingEarly Phase 1
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes
United States27 participantsStarted 2025-07-03
Plain-language summary
This study aims to understand the heart and blood sugar health benefits of using an adjunctive therapy to lower high insulin levels in people with type 1 diabetes. The investigators will also look at people with a specific type of diabetes called Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) and those without diabetes to help interpret the results. The investigators will use a medication that helps the body get rid of sugar, called and SGLT2 inhibitor, with the goal to reduce the body's insulin requirements. The investigators believe this could lead to better heart and blood sugar health, including a better response to insulin and more available nitric oxide, a gas that helps blood vessels function well. The investigators will compare heart and blood sugar health risk factors in participants with type 1 diabetes, participants with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), and non-diabetic healthy volunteers under two conditions: high insulin levels typical of type 1 diabetes and normal insulin levels typical of the other two groups.
Who can participate
Age range
18 Years – 60 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:
Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg
T1DM Participants:
Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery
GCK-MODY Participants:
HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing
Control Participants:
HbA1c: less than 5.5%
\*\* Exclusion Criteria: Severe Hypoglycemia: ≥1 episode in the past 3 months
Comorbidities:
* Any hospital admissions for diabetic ketoacidosis in the past 6 months
* SBP greater than 140 mmHg and DBP greater than 100 mmHg
* eGFR by MDRD equation of less than 60 mL/min/1.73 m²
* AST or ALT greater than 2.5 times ULN
* Hct less than 35%
Medications:
* Any antioxidant vitamin supplement within 2 weeks before the study
* Any systemic glucocorticoid
* Antipsychotics
* Atenolol, Metoprolol, Propranolol
* Niacin
* Any thiazide diuretic
* Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
* Growth hormone
* Any immunosuppressant
* Antihypertensive
* Any antihyperlipidemic
Other:
* Pregnancy
* Tanner stage less than 5
* Peri- or post-menopausal women
* Active smoker
T1DM Participants:
Medications: Any diabetes medication except insulin C-peptide: greater than 0.7 ng/mL (fasting)
GCK-MODY Participants:
None specific
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.