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New treatment option for type1diabetes
Official title Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06105931
What this study is testing
What is Hyperinsulinemic-euglycemic clamp?
Hyperinsulinemic-euglycemic clamp is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type1diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 30
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 to ≤30 years
- Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2.
- HbA1c ≤10%
You likely can't join if
- Current use of adjunctive diabetes medication or anti-obesity medication
- Insulin dose \<0.5 units/kg/day
- Use of lipid lowering prescription medication other than statins or omega-3 products
- Doesn't meet MRI safety criteria or having claustrophobia
- Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease
- Known renal impairment
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 to ≤30 years
- Diagnosed T1D for at least 12 months and with BMI \<25 kg/m2.
- HbA1c ≤10%
- Clinical use of continuous glucose monitoring (CGM)
- Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year:
- Baseline creatinine \>1.0mg
- Hypertriglyceridemia (\>400 mg/dl)
- ALT ≥3.5 times the upper normal limit (UNL)
- Current use of adjunctive diabetes medication or anti-obesity medication
- Insulin dose \<0.5 units/kg/day
- Use of lipid lowering prescription medication other than statins or omega-3 products
- Doesn't meet MRI safety criteria or having claustrophobia
- Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease
- Known renal impairment
- Pregnancy or lactation, or planning to become pregnant during the study period.
- Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.
- Treatment with another investigational drug within the past 1 month
- Past medical history of or self-reported corn allergy
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.